Intra-vaginal devices and methods for treating fecal incontinence

ABSTRACT

Devices and methods for intra-vaginal bowel control.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation and claims priority under 35 U.S.C. §120 to U.S. application Ser. No. 14/293,365 filed Jun. 2, 2014, which isa continuation of U.S. application Ser. No. 13/679,484 filed Nov. 16,2012 (now U.S. Pat. No. 8,740,766), which is a continuation of U.S.application Ser. No. 13,625,683 filed Sep. 24, 2012 (now U.S. Pat. No.9,289,278), which is a continuation-in-part of U.S. application Ser. No.13/635,598 filed on Sep. 17, 2012 (now U.S. Pat. No. 9,072,578), whichis a national phase application of International Application No.PCT/US2011/028691, filed Mar. 16, 2011, which claims the priority ofU.S. Provisional Application No. 61/314,335 filed Mar. 16, 2010 and U.S.Provisional Application No. 61/367,418 filed Jul. 25, 2010. Saidapplication Ser. No. 13/625,683 also claims priority to U.S. ProvisionalApplication No. 61/538,095 filed Sep. 22, 2011 and to U.S. ProvisionalApplication No. 61/704,433 filed Sep. 21, 2012.

All of the aforementioned applications are incorporated by referenceherein.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

BACKGROUND

Fecal incontinence (FI) is one of the most common health problems inwomen. The prevalence of FI is not well understood, primarily becausethe stigma surrounding the condition and the lack of viable treatmentshave deterred many women from seeking medical care. Recent generalpopulation surveys indicate the prevalence of FI at 9% to 12% and ashigh as 24% in older women. These studies have also shown that, althoughprevalence increases somewhat with age, younger women have surprisinglyhigh prevalence rates. The condition is both physically limiting andemotionally devastating. Those afflicted are often forced to withdrawfrom social and professional activities and often face problems in theirprivate personal relationships.

The cause of FI is multifactorial and not completely understood. Oftentimes, women with FI have a history of damage to the pelvic floorstemming from pregnancy and childbirth. Damage can involve the internaland external anal sphincters, pelvic floor muscles, and associatednerves (e.g., pudendal nerve). Puerperal damage to these structures maynot manifest until later in life, possibly due to age-related changes inrectal sensation, compliance, and volume, in addition to furtherweakening of the sphincters and pelvic floor muscles. Many women with FIhave multiple defects in their continence system, making effectivetreatment particularly difficult.

Existing treatments for FI have had limited success. Conservativemedical management, such as dietary modification, antimotility agents,and biofeedback, has not been very effective. Overlapping sphincterrepair is one of the most common surgical approaches. However, long-termsuccess rates have been less than 40% and the procedure is usually onlyapplicable for certain, repairable sphincter defects. The implantableartificial bowel sphincter (American Medical System's Acticon®Neosphincter) is a surgical device that gives the patient dynamiccontrol of the opening and closing of the anorectal canal. Thismechanism of dynamic control has shown effectiveness; however, the highmorbidity related to its invasive nature has greatly limited itsapplicability. Such surgical interventions also require inpatienthospitalization and prolonged recovery. Recently, sacral nervestimulation (SNS) has been used to treat FI. Its mechanism is not fullyunderstood and is applicable to patients willing to undergo a permanent,surgical implant. Injectable bulking agents, such as dextranomer instabilised hyaluronic acid, have been used to treat FI, but they haveshown limited efficacy over longer durations. Without viable treatmentsavailable, most FI patients are resigned to coping with the condition byusing products such as pads and adult diapers.

An intra-vaginal device adapted to control stool passage through therectum could provide a new way of treating FI in women.

U.S. Patent App. Pub. No. 2006/0211911 to Jao, et al. (“Jao”) disclosesa vaginal insert having a cylindrical front projection 11 and head 20.In use, and as shown in FIG. 6, a user, holding head 20, inserts thecylindrical front projection 11 into the vagina 30 to push therectovaginal septum 50 outward against the rectum 40, thereby guidingaccumulated excrement 70 back to the rectum 40. In general, Jaodescribes a device that is repeatedly and manually inserted andmanipulated to aid in the removal of accumulated stool, and fails todescribe occluding the rectum to prevent the passage of stool.

U.S. Pat. No. 6,013,023 to Klingenstein (“Klingenstein”) generallydescribes a device to control fecal incontinence. Klingenstein includesan embodiment with stabilizing features disposed external to the vagina,which can be uncomfortable and cumbersome for patients. Klingensteinalso describes an embodiment without external stabilizing features. Thisdesign, however, is not adapted for stability in the vagina in theexpanded and unexpanded states of the device. This is problematic whentrying to repeatedly and reliably control the expansion of theexpandable component. An additional drawback to Klingenstein is that hisdevice is not designed and configured to allow slack in the vaginaltissue to effectively occlude the rectum. Additional deficiencies of theKlingenstein disclosure are set forth herein.

A class of products generally referred to as pessaries have beentypically used and indicated for the treatment of pelvic organ prolapse.In this regard pessaries are positioned intra-vaginally to supportorgans, such as the uterus, from prolapsing into the vaginal canal.There are also a variety of other intra-vaginal devices that have beenused for birth control, urinary incontinence, and other conditions.These devices have a variety of shapes. Some have the ability to expand,but no pessaries are indicated for the treatment of FI and thedeficiencies of these devices will be set forth below.

A need exists for an effective intra-vaginal device adapted to stablyand comfortably occlude the rectum to control stool passage for treatingfecal incontinence.

SUMMARY OF THE DISCLOSURE

One aspect of the disclosure is an intravaginal device for the controlof passage of stool in an adult human female user, the device comprisingan occluding portion; and the device being sized and configured tomaintain position and stability through engagement of internal vaginalanatomy during a first state wherein the occluding portion is notextended and a second state wherein the occluding portion extends to atleast partially occlude the rectum.

In some embodiments the device is sized and configured to at leastpartially occlude the user's rectum proximal to the perineal body.

In some embodiments the device comprises a stabilizing portion to whichthe occluding portion is secured.

In some embodiments the device includes a control element that allowsthe user to control the extension.

One aspect of the disclosure is an intravaginal device for the controlof passage of stool in an adult human female user, the device comprisingan occluding portion; and the device being sized and configured tomaintain position and stability through engagement of internal vaginalanatomy during a first state wherein the occluding portion is notextended and a second state wherein the occluding portion extends to atleast partially occlude the rectum; wherein said device is sized andconfigured to fit entirely proximal to the inferior pubic ramus.

In some embodiments the device is sized and configured so that thedistal portion of the device is disposed in the anterior portion of thevagina adjacent the pubic symphysis when the device is in the first andsecond states. The device can be configured so that the distal portionof the device fits in the notch formed near the pubic symphysis.

In some embodiments the device is sized and configured to fit betweenthe areas of the ischiopubic ramus and posterior fornix.

One aspect of the disclosure is an intravaginal device for the controlof passage of stool in an adult human female user, the device comprisingan occluding portion; and a stabilizing portion supporting the occludingportion; and the device being sized and configured to maintain positionand stability through engagement of internal vaginal anatomy during afirst state wherein the occluding portion is not extended and a secondstate wherein the occluding portion extends to at least partiallyocclude the rectum; wherein the stabilizing portion is flattened to havea thickness relatively less than the length of the occluding portion.

In some embodiments the stabilizing portions flattens in the proximityof the occluding portion.

In some embodiments the occluding portion extends from the stabilizingbody at an angle between about 45 degrees and about 135 degrees from thestabilizing body.

In some embodiments the stabilizing portion has a generally roundedproximal end.

In some embodiments the ratio of the thickness of the stabilizingportion to the extension length of the occluding portion is less thanabout ⅔.

In some embodiments the thickness of the stabilizing portion is lessthan about 2.5 cm.

In some embodiments the thickness of the stabilizing portion is lessthan about 2.5 cm in the proximity of the occluding portion.

One aspect of the disclosure is an intravaginal device for the controlof passage of stool in an adult human female user, the device comprisingan occluding portion; and the device being sized and configured tomaintain position and stability through engagement of internal vaginalanatomy during a first state wherein the occluding portion is notextended and a second state wherein the occluding portion extends to atleast partially occlude the rectum; wherein a lateral span of the deviceis greater than the width of the occluding portion.

One aspect of the disclosure is an intravaginal device for the controlof passage of stool in an adult human female user, the device comprisingan occluding portion; and the device being sized and configured tomaintain position and stability through engagement of internal vaginalanatomy during a first state wherein the occluding portion is notextended and a second state wherein the occluding portion extends to atleast partially occlude the rectum; wherein said occluding portion isdisposed on a proximal half of the device.

One aspect of the disclosure is an intravaginal device for the controlof passage of stool in an adult human female user, the devicecomprising: an occluding portion; and the device being sized andconfigured to maintain position and stability through engagement ofinternal vaginal anatomy during a first state wherein the occludingportion is not extended and a second state wherein the occluding portionextends to press against the rectovaginal septum to at least partiallyocclude the rectum; and a cushioning portion.

In some embodiments the cushioning portion is located proximally on thedevice to be in the proximity of the cervix.

In some embodiments the cushioning portion is located opposite theoccluding portion.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1D are perspective, bottom, side, and front views of anexemplary intra-vaginal device.

FIGS. 2A-2B are cross-sectional views of the body showing the positionof an exemplary intra-vaginal device.

FIG. 3A is an exploded view of an exemplary device and FIG. 3B shows afolded device for insertion.

FIGS. 4A-4E are top views of exemplary stabilizing body sizes.

FIGS. 5A-51 are views of exemplary stabilizing body profiles.

FIGS. 6A-6D show an exemplary application of force to the expandingmember, and FIGS. 6E-6F show the expanding member with a supportivemember.

FIGS. 7A-7G show cross-sectional views of the vagina and rectum with theeffect of vaginal displacement due to shapes of exemplary intra-vaginaldevices.

FIGS. 8A-8M show alternative stabilizing body and anterior end shapes.

FIGS. 9A-9C show the device including a cap with the inflationmechanism.

FIGS. 10A-10B are side views of an exemplary device with a spring in theexpandable member.

FIGS. 11A-11B are side views of an exemplary device with a spring in theexpandable member.

FIGS. 11C-11D are side views of an exemplary device showing one methodof operating the inflation mechanism.

FIGS. 11E-11F show views of an exemplary expandable member withreinforcements.

FIGS. 12A-12C show views of an exemplary device to accommodate a largercervix.

FIGS. 13A and 13B are side views of an exemplary device with additionalocclusion mechanisms.

FIGS. 14A-14G are side views of an exemplary device.

FIGS. 15A-15G are views of an exemplary device.

FIGS. 16A-16E are views of an exemplary device with grips or suctionmechanisms.

FIGS. 17A-17B are views of an exemplary device fitting with the cervix.

FIGS. 17C-17E are side views of an exemplary device collapsing andexpanding.

FIGS. 18A-18B are perspective views of an adjustable expandable member.

FIGS. 19A-19D are views of an exemplary expandable member beingadjustable angularly both in and out of the body.

FIGS. 20A-20G are side views of an exemplary device wherein the anteriorend and posterior end are decoupled.

FIGS. 21A-21D are perspective views and top views of an exemplarydevice.

FIGS. 22A-22B are side views of an exemplary device wherein theexpandable member expands in an opposite direction.

FIGS. 23A-23C are views of exemplary latching mechanisms.

FIGS. 24A-24B are views of exemplary attaching mechanisms formaintaining the exemplary inflation mechanism in the vagina.

FIGS. 25A-25B are views of an exemplary inflation mechanism as a tube.

FIGS. 26A-26B are side views of a device with active contraction.

FIGS. 27A-27B are perspective views of a device with irreversibleremoval.

FIG. 28A is a side view of an external inflation mechanism.

FIGS. 28B-28D are views of a device with a mechanism for directing theinflation mechanism to a valve.

FIG. 29 is a side view of an electromagnetic inflation mechanism.

FIGS. 30A-30B are views of a device with a retractable inflatablemechanism.

FIGS. 31A-31C are views of different shaped expandable members.

FIGS. 31D-31G are views of a device with suction mechanisms.

FIGS. 32A-32B are views of the device with a bleed mechanism.

FIGS. 33A-33B are side views of a threaded toggle mechanism.

FIG. 33C is a side view of a snap-fit locking mechanism.

FIGS. 34A-34B show the line formed between the anterior and posteriorends.

FIGS. 35A-35C are side views of a device with a single use reservoir.

FIGS. 36A-36C are side views of a device with a single use syringe.

FIGS. 37A-42B illustrate views of an exemplary intra-vaginal device forthe control of stool passage.

FIG. 43 is a perspective view illustrating the bones of the pelvis of ahuman.

FIGS. 44A-44F illustrate an exemplary method of positioning an exemplarydevice within the vagina.

FIG. 45 shows an inferior and slightly anterior view of FIG. 44F.

FIG. 46 illustrates an exemplary device with an occluding portion in anextended configuration within a user's vagina.

FIG. 47 illustrates an exemplary device within a user's vagina and anoccluding portion that is extended.

FIGS. 48A-48B illustrate exemplary dimensions of devices set forthherein.

FIG. 49 illustrates an exemplary device and an exemplary occludingportion.

FIGS. 50 and 51 illustrate a first and second layer that are adapted tomove with respect to one another.

FIGS. 52A-C illustrate an exemplary device and its positioning within avagina.

FIGS. 53A-82D illustrate exemplary intra-vaginal devices and exemplarycomponents thereof.

FIGS. 83-84 illustrate an exemplary occluding portion.

FIGS. 85A-85B illustrate an exemplary occluding portion.

FIGS. 86A-86B illustrate an exemplary occluding portion.

FIGS. 87A-87B illustrate an exemplary occluding portion.

FIGS. 88A-88B illustrate an exemplary intra-vaginal device for thecontrol of stool passage.

FIGS. 89A-B illustrate an exemplary occluding portion.

FIGS. 90A-C illustrate an exemplary intra-vaginal device for the controlof stool passage.

FIGS. 91 and 92 illustrate an exemplary intra-vaginal device for thecontrol of stool passage.

FIGS. 93A and 93B illustrate an exemplary intra-vaginal device for thecontrol of stool passage.

FIGS. 94-96 illustrate an exemplary occlusion control device and itsmethod of use.

FIG. 97 illustrates an exemplary occlusion control device and its methodof use.

FIG. 98 illustrates an exemplary occlusion control device and its methodof use.

FIGS. 99 and 100A-B illustrate an exemplary way to release fluid fromwithin an occluding portion.

FIGS. 101-103 illustrate an exemplary modular device.

FIGS. 104A-B illustrate an exemplary passive occluding device.

FIGS. 105A-B illustrate an exemplary device that includes a pressuregauge.

FIGS. 106A-B illustrate an exemplary tactile indicator.

FIGS. 107A-B illustrate an exemplary device that utilizes magnetic forceto occlude the rectum.

FIG. 108 illustrates an exemplary intra-vaginal magnetic device with ahandling portion.

FIG. 109 illustrates an exemplary diaphragm-like device.

FIG. 110 illustrates an exemplary way to secure a magnet in place.

FIG. 111A-B illustrate exemplary stabilizing portions.

FIG. 112 illustrates an exemplary stabilizing portion that includes adistal end that extends upwards relative to the proximal end.

FIGS. 113A-C illustrate exemplary modular designs.

FIG. 114 illustrates an exemplary intra-vaginal device for controllingstool.

FIG. 115 illustrate a portion of an exemplary stabilizing portion.

DETAILED DESCRIPTION

The disclosure herein relates generally to intra-vaginal devices andmethods for controlling the passage of stool. The devices are adapted toat least partially occlude the rectum to control the passage of stoolwhile remaining stable inside the vagina.

Extensive cadaver testing and human clinical testing and trials wereperformed in order to understand key attributes for devices that willachieve the desired vaginal bowel control (VBC). First, the ability toachieve rectal occlusion was found to be influenced by a variety ofdesign features that were unanticipated from knowledge of the anatomy.Second, the stability of the device not only during rectal occlusion butalso when the device is not occluding the rectum turned out to be a keyaspect of device function and required specific adaptations to ensurethe device is stabilized when it is not occluding and when it isoccluding. Finally, the devices have to be adapted to interact with thetissue in a way that is comfortable and safe to the user while achievingocclusion and stability. Through bench and human clinical testing, thesediscoveries of how device design impacted device performance includingrectal occlusion, device stability, and user safety and comfort, led tothe development of inventive and effective vaginal bowel controldevices.

While the disclosure herein focuses on the control of stool passage totreat FI, the devices, systems, and methods of use herein can be used oradapted to be used in one or more other bowel control applications, suchas in, for example, the treatment of irritable bowel syndrome (“IBS”),strong urgency to have a bowel movement, diarrhea, loose stools,frequent bowel movements, flatal incontinence, constipation, hardstools, irregular or infrequent bowel movements, abdominal pain ordiscomfort, cramps, bloating, incomplete stool evacuation, andrectoceles. By compressing the rectum, the device may mitigate the urgeto have a bowel movement that comes from a distended rectum, or via somerelated neurological feedback disruption. In reducing the urge ormechanically blocking stool from passing, it may also increaseabsorption of liquids from the stool passing through the GI tract,causing less frequent stools and stools that are not as loose in nature.Since these symptoms are often associated with abdominal pain ordiscomfort, especially in patients with IBS, the devices may help withthose symptoms. The devices may also help women become more regular ifthey are constipated or have hard stools by compressing anddecompressing the rectum, thereby applying a regular stimulus that canencourage stool passage. In patients who have a rectocele where stoolcollects and they may not completely evacuate, the devices can correctthe rectocele or deflect it back into a position where stool can exitnormally. Additionally, the devices herein can be used or adapted to beused in the treatment of gastrointestinal conditions that may be relatedto bowel habits or colon and rectum function, for examplediverticulitis, hemorrhoids, anal fissures.

One aspect of the disclosure is an intra-vaginal device for the controlof rectal volume of an adult human female user, the device comprising arectal compressing portion and a stabilizing portion, wherein bothportions being sized and configured to maintain position and stabilitywhile fitting entirely within the vagina and compressing the rectum.Previous attempts have failed to describe or teach an entirelyintra-vaginal device designed for stably compressing the rectum.

In this disclosure, the rectal compressing portion may also be referredto as an occluding portion or a force applying portion, and similarly,the act of compressing the rectum may also be referred to as occludingthe rectum or applying a force towards the rectum. While mostembodiments described herein are described as reversibly occluding, orhaving occluding and non-occluding states, it is possible for a devicein a non-occluding state to still apply some small amount of force onthe rectovaginal septum, creating a minor deflection or occlusion of therectum. However, any such minor forces are inconsequential for theeffects on the bowels described herein. A stabilizing body herein couldalso be referred to as a stabilizing portion. The stabilizing portionand occluding portion are not necessarily different parts, but ratheraspects of the device named here for convenience of description. It isthe design and configuration of the devices as a whole (including theconfiguration of the stabilizing and occluding portions and theirrelationship to each other) that produces the stability, occlusion, andcomfort necessary for function.

One aspect of the disclosure is a rectal compressing portion that isextendable or expandable, allowing it to reversibly compress the rectum.The device is an intravaginal device adapted to maintain position andstability in both extended and non-extended states. One of the drawbackswith previous attempts at stool control is that they fail to teach ordescribe devices that are intra-vaginally stabilized when an expandableportion is in a non-extended state. One of the advantages of the devicesherein is that they are sized and configured to stabilize and maintainthe device in a desired orientation when the occluding portion is in anon-occluding state. Additionally, the devices are sized and configuredto stabilize and maintain the device in the desired orientationthroughout repeated changes between occluding configurations andnon-occluding configurations. Additionally, the devices are sized andconfigured to cause the occluding portion to repeatedly extend againstthe recto-vaginal septum in a desired extension direction to at leastpartially occlude the rectum even after the occluding portion hastransitioned to a non-occluding state. Additionally, the devices aresized and configured to extend against the same part of therecto-vaginal septum, and as later described, the location on therectovaginal septum where the portion extends is important.Additionally, the devices are sized and configured to maintain theoccluding portion extended against, and in a position where it can bereadily extended against, rectovaginal septum in extended andnon-extended states, respectively.

It has been discovered through testing that how the device is designedto engage and be positioned within the surrounding anatomy is importantfor stabilizing the device and occluding the rectum. One aspect of thisdisclosure is a device configured to fit proximal to the area of thepubic ramus in order to stabilize the device when the occluding portionis extended and non-extended. Vaginal bowel control devices designed andconfigured to engage the anatomy as described allow for increasedstability when the occluding portion is in extended and non-extendedstates. It is further described below how the device is designed andconfigured to engage the surrounding internal vaginal anatomy forstabilization in occluding and non-occluding states.

Through the course of experimentation, another important discovery wasto compress the rectum proximal to the perineal body. During humanclinical testing, it was more difficult to obtain intravaginal rectalocclusion with the same posterior force application in the area of theperineal body than in the area proximal to the perineal body. Thisresult was unanticipated because the rectal canal is narrower in theregion of the perineal body. Users also felt greater discomfort whenforce was applied to the perineal body as compared to proximal to theperineal body. Therefore, one aspect of this disclosure is a devicedesigned and configured to stably and repeatedly compress the rectumproximal to the perineal body. This development, as a result of clinicalfindings, is different than might be suggested based on other mechanismsin medical devices for bowel control. For example, the Acticon®Neosphincter, which also compresses the anorectal canal to control stoolpassage, is placed at the level of the perineal body.

It was also discovered through cadaver and human clinical testing thatthe device's effect on surrounding vaginal tissue affects the ability ofthe device to occlude the rectum. More specifically, if too much slackor redundancy is taken out of the surrounding vaginal tissue by a devicedistending the vaginal tissue, it makes it more difficult for the deviceto occlude the rectum. Furthermore, it was found to be less comfortablefor the user if the device compresses the rectum when the slack has beentaken out of the vaginal tissue. In addition to discomfort, this placesadditional strain on the tissue and could lead to pressure ulceration,necrosis, or other adverse events. The discovery of this relationship inthe tissue resulted in a variety of design features in the devicesherein. One aspect of this disclosure is a device designed andconfigured to minimize the stretch to the vaginal tissue whilemaintaining stability and compressing the rectum posteriorly. Thebalance of configuring a device to be stable in the vagina but alsoreducing stretch on the surrounding tissue in order to occlude therectum was an important design development. Previous attempts have notdescribed a vaginal device for stool control that is designed tomaintain sufficient slack in the vaginal tissue. Additionally, it wasfound to be important to reduce the stretch on the surrounding vaginaltissue in proximity to the extendable portion during rectal compression.

A variety of device features were developed in order to minimize thestretch to the vaginal tissue while maintaining stability andcompressing the rectum posteriorly. Such features, described in furtherdetail below, include the dimensions of the stabilizing body, dimensionsof the occluding portion, and the relationship between the dimensions ofthe stabilizing body and occluding portion; as well as theirpositioning, absolute and relative to each other.

One aspect of this disclosure is a device designed and configured with aflattened stabilizing portion in relation to the occluding portion. Morespecifically, the stabilizing body is flattened in a directionsubstantially perpendicular to the direction of occluder extension. Morespecifically, the stabilizing portion has a thickness less than thelength of the occluding portion. In this disclosure, a flattenedstabilizing portion can also be described as: a portion whose thicknessin the direction perpendicular to its lateral span and locallongitudinal axis is less than the lateral span; particular range ofwidth, length and thickness ratios describing a reduced thickness; across-sectional profile (taking the cross-sectional cut with a planenormal to the longitudinal axis of the device, or a plane normal to theproximal-distal axis of the vagina when the device is in-situ) that isrelatively short, compared to its width; or a generally planar shape.The elements of such a profile are important for several reasons thatwere discovered through clinical testing. A stabilizing portion that isflattened relative to the occluding portion, and more specifically in adirection substantially perpendicular to the direction of extension ofthe occluding portion, provides enough slack in the vaginal walls inorder to allow the extendable portion to better and more comfortablycompress the rectum. This is in contrast with work disclosed in theprior art attempts, some of which describes a bulky, tubular base. Atthe same time, a flattened stabilizing portion with appropriatedimensions was also found to contribute to device stability by resistingrotation and translation from forces generated by rectal occlusion, asdescribed further below. A flattened stabilizing portion relative to adirection of extension of the occluding portion also allows the deviceto fit in the area between the pubic ramus and the posterior fornix.More specifically, it allows the distal end of the device to fitanteriorly in the area of the pubic notch. The positioning that isachieved based on the design contributes to device stability by keepingit snug to the surrounding tissue and better occlusion by helping keepthe occluding portion proximal to the perineal body.

An exemplary intra-vaginal device 10 that is used to control stoolpassage is shown in FIGS. 1A-1 D. The intra-vaginal device 10 includes astabilizing body 12 for securing the device around the area of the pubicnotch and posterior fornix and for supporting a force-applying portion18. The force applying portion 18 can reversibly apply a force to therecto-vaginal septum (the tissue separating the vagina from the rectum)which has the effect of inhibiting the passage of stool through therectum. This force application can be as shown in FIGS. 2A and 2B,wherein the force application is made via a member expanding against therecto-vaginal septum.

Preferably, the device 10 is designed for the anterior region 14 to fitin the area of the pubic notch. The pubic notch is formed in theanterior vagina, resulting from the structure of the surrounding pelvicfloor muscles, providing a stable anchoring point for the anterior end14 of the device. Preferably, the posterior end 16 of the device 10 fitsinto the area of the posterior fornix. This is the deepest region of thevagina (i.e. the vaginal vault) behind the cervix. In patients without acervix, e.g. those who have undergone a hysterectomy, the device stillrests in the same area, which is the deepest extension of the vagina. Adevice designed to fit in this region has added security and stability.A more preferable embodiment is designed to fit in both of these areasto provide stability. A device designed for securing in theaforementioned locations will ensure that when placed properly, it restsoutside of the region where the vagina is highly innervated, making thedevice comfortable for the patient. Additionally, the design of thepreferred device, by engaging these locations, ensures easy repeatablepositioning when the device is inserted, and further ensures positionalcertainty and stability such that when the device is inserted, it is inthe correct position to apply force to the appropriate portion of therecto-vaginal septum, and can do so over multiple inflation/deflationcycles without the need for repositioning.

The force applying portion 18 is preferably an expandable member, andmore preferably an inflatable member such as a balloon, though othermechanisms are considered below.

The inhibition of stool resulting from the application of force is dueto the force the device applies to the rectum, which disallows thenormal expansion of the rectal lumen, which normally occurs toaccommodate stool. This action can be described as applying a force todeflect the recto-vaginal septum to compress the rectum, or as generallypreventing the expansion of the rectum by applying a force to it.Alternatively, the force applying portion can reversibly apply a forceagainst the vaginal wall opposite of the recto-vaginal septum, whichwould prevent stool passage by pressing the stabilizing body, or anadditional expandable member, against the rectovaginal septum.

The stabilizing body preferably includes a portion proximate to theforce applying portion that has a narrow lateral span, such that wheninserted, there is minimal distention of, and tension in, the walls ofthe vagina proximate to the force applying portion.

The stabilizing body 12, preferably has an anterior end 14 and aposterior end 16 operatively connected by a portion 20 or 12, which hasa narrow lateral span and includes the force applying member 18, suchthat when inserted, the anterior end 14 preferably rests around thepubic notch and the posterior end 16 preferably rests in the posteriorfornix of the vagina, thereby stabilizing and maintaining the positionof the intra-vaginal device 10 while minimizing pressure or tension tothe lateral walls of the vagina, as shown in FIGS. 2A and 2B. Thisportion of narrow lateral span can be considered as a central portion ofthe stabilizing body, or can also be considered as a posterior portionof the stabilizing body.

The preferred embodiment described above minimizes the imparting oftension in the lateral vaginal walls by having a narrow lateral span,especially in proximity to the force applying portion. In a morepreferred embodiment, the width narrows from the anterior end 14 to theportion including the force applying portion 18 (FIGS. 1A and 1B), andalso considered is a device that narrows from the posterior end 14 tothe central portion (Insert FIG. 40A). Alternatively, the anterior end,14 and the posterior end 16 can be connected by a more generallyelongate portion, such as a rod (FIG. 8, item 12), thus avoidingpressure application on the lateral walls.

The width of the expandable portion can be 1-6 cm, more preferably 3-4cm. The length of the expandable portion can be 1-6 cm, more preferably2-5 cm. The main body proximate to the expandable portion can be lessthan 7 cm and more preferably less than 5 cm in width to reduce tensionin the vaginal walls.

It is important that the intra-vaginal device 10 not utilize lateraldistention of the vagina for fixation when applying pressure to therectum to occlude stool. FIG. 7A shows a cross-section of the vagina andrectum, wherein the vagina has plenty of slack redundant tissue in foldsalong the wall. FIGS. 7B and 7C show an intra-vaginal device with awider body that takes out the slack in the vagina walls, making itdifficult to utilize the recto-vaginal septum to occlude the rectum.Since the device creates significant lateral distension on the adjacentwall, the wall loses its redundancy and elasticity and is not easilymanipulated by the expandable portion. FIGS. 7D-E show the intra-vaginaldevice 10 of the present disclosure, wherein the device 10 takesadvantage of the vaginal redundancy to push on the rectum. In otherwords, sufficient slack is still present in the vagina once the device10 has been inserted, allowing the vaginal walls to be manipulated suchthat the rectum is occluded. This configuration allows stability andcomfort while providing the function of occluding the rectum. Therefore,the present disclosure provides for an intra-vaginal device 10 for thecontrol of stool, including a main body 12 having an anterior end 14 anda posterior end 16, wherein the anterior end 14 and posterior end 16 areoperatively interconnected by a portion or sides 20, which include aforce applying member 18, such that the aforementioned portion or sidesproduce minimal displacement adjacent to lateral walls of a patient'svaginal wall allowing for occlusion of the rectum by the expandablemember 18.

In order to further prevent lateral pressure on the vaginal walls, thesides 20 can laterally narrow when the expandable member is expanded. Asshown in FIG. 7E, pressure “a” on the sides 20 when the expandablemember expands can cause the sides 20 to narrow laterally. This is alsoshown in FIGS. 7F and 7G.

The stabilizing body 12 can also include extensions extendingperpendicular to an axis formed by a line between the pubic notch andposterior fornix, wherein the extensions prevent rotation around theaxis. The extensions can extend in a different direction as thedirection of the force applying portion 18. The extensions can beperpendicular to the direction of said force applying portion 18. Thestabilizing body 12 and the extensions can be a substantially planarstructure.

The terms “occluding” or “occlude” as used herein, refer to restrictingor obstructing the passage of stool through the rectum. The occlusioncan be a full obstruction of the rectum, or it can be a partialobstruction. It is desired to prevent damage to the tissue separatingthe rectum from the vagina, herein referred to as the “recto-vaginalseptum”, so the recto-vaginal septum is not overly stretched, but merelyheld in place against, or displaced towards, the opposite side of therectum and prevented from expanding in at least one direction to allowthe normal passage of stool.

The term “toggling” or “toggle” as used herein, refer to the ability ofan object (i.e. the occluding member 108 further described herein) toalternate between two or more positions. The toggling can beaccomplished by mechanical or electronic mechanisms further describedbelow.

The stabilizing body 12 of the device 10 can be made of wire forms 22enclosed in tubing 24, as shown in FIG. 3A. The wire forms 22 can be inany suitable configuration, but preferably, there is a wire form 22 foreach side of central portion 20. In other words, preferably, the centralportion 20 is two sides 20, but a single central portion 20 can be used.Any suitable wire can be used that will provide enough strength tomaintain the shape of the device. Alternatively, a polymericreinforcement can be used in place of, or in conjunction with, the wireforms. The tubing 24 is preferably silicon, but other materials can beused that are biocompatible. The surface of the stabilizing body 12 caninclude grips 52 on its surface in order to stabilize the device againsttissue that it contacts. The grips 52 are small enough and shaped sothat the tissue is not damaged or irritated by use. The grips 52 canalso be a suction mechanism such as pocks that hold the stabilizing body12 in place with a vacuum, as shown in FIGS. 31D, 31F. The stabilizingbody 12 can also be inflatable, in order to help with insertion andremoval.

In a preferred embodiment, the stabilizing body 12 is generally narrow,with the posterior end 16 being approximately of the same width as theforce applying portion 18 and in a rounded shape, and the anterior end14 being slightly wider and in a squared shape in order to fit securelyaround the pubic notch, and further so as not to unduly take out theslack in the vagina walls. The widened anterior end 14 can be a surfacethat is curved to approximate the curvature of the pelvic floor musclesinterfacing therewith, shown in FIGS. 8K-8M. The roundness of theposterior end 16 also eases insertion and prevents irritation to thevaginal walls. The squareness (i.e. larger flat section before curvinginto the corners) of the anterior end 14 further helps in preventing thedevice 10 from rotating within the body. The lateral span of the portion20 proximate to the force applying portion 18 can be slightly wider thana width of the force applying portion 18.

The anterior end 14 and the posterior end 16 preferably include springs26, or other members that are at least in part flexible, that join thewire forms 22 in the stabilizing body 12 together. The springs 26 andthe wire forms 22 can be operatively connected by any mechanism known inthe art, including silicone, which can be overmolded over the wireforms.The springs 26 allow the device 10 to be folded along its length foreasier insertion and return the device 10 to its open configuration onceinside the vagina and in the preferred position around the pubic notchand in the posterior fornix. The springs 26 allow the device 10 toconform more naturally to the contours of the vagina. The springs 26 canalso or alternatively be located between the anterior end 14 andposterior end 16 along the stabilizing body 12 such that the ends 14, 16are decoupled from each other (as shown in FIGS. 20A-20G). The springs26 further prevent force being imparted on one end 14, 16 from beingdirectly transmitted to the other end 14, 16. For example, body forcesdue to the abdominal contents above the vagina, or forces due to a forceapplying portion 18 will have less of an effect on the stability of theanterior end 14 if they are connected by a flexible component. The wireforms 22 provide stiffness in the longitudinal direction. The foldedconfiguration is shown in FIG. 3B. Alternatively, the stabilizing body12 can also be made out of memory materials, alloys, or a contiguousflexible polymer that can return to an open shape after being folded forinsertion.

The device 10 can be manufactured according to methods known in the art.For example, silicon adhesive or heat bonding can be used in assembly,or the device 10 can be injection molded as one single piece. Thestabilizing body 12 can be glued together or heat melded, and the forceapplying portion 18 can be injection molded.

The stabilizing body 12 can also be manufactured in various sizes andshapes as shown in FIGS. 4A-4D. The central portion 20 of the device 10can easily be shortened or lengthened to provide different sizes. Theanatomy of every woman is different, and having various sizes and shapesavailable of the device 10 can allow for many different women to use thedevice 10. A suitable device 10 can be determined by a trial and errormethod of insertion. Alternatively, a CAT scan can be performed orX-rays taken, or other medical imaging technologies (ultrasound, MRI) tomeasure the dimensions of the vagina and rectum, in order to choose apreexisting device 10 or to custom manufacture the device 10 for aparticular body. Additionally, specific tools such as a highlyadjustable device or device proxy can be used to determine the correctsize and shape for a given patient.

The stabilizing body 12 can also be not completely straight when viewedfrom a sagittal plane, but include an upward angled or curved anteriorend 14 (FIGS. 5A-E), a stepped stabilizing body 12 (FIG. 5F), a bowedstabilizing body 12 (FIG. 5G), or an upward angled central portion ofthe stabilizing body 12 (FIG. 5H-I). In other words, the stabilizingbody 12 can include a portion that raises above the line formed by theanterior end 14 and the posterior end 16 (this line is shown in FIG.34A-34B). These different shapes of the stabilizing body 12 can aid instability of the device 10 in different anatomies.

The force applying portion 18, preferably in the form of an expandablemember 18 and referred to as such herein interchangeably, at theposterior end 16 can be actuated between an expanded state and acontracted state in order to either prevent stool from passing throughthe rectum by pressing against the recto-vaginal septum and preventingthe rectum from expanding to allow passage of stool (expanded state) orto allow stool to pass through the rectum (contracted state). Theexpandable member 18 is also preferably in the contracted state uponinsertion, and can fold into the stabilizing body 12 and into itself forease of insertion. However, the device 10 can also be inserted with theexpandable member 18 at least partially expanded, and merely providingmeans for contracting the expandable member 18 (or allowing it to becompressed) to allow the passage of stool.

The expandable member 18 can be in various shapes and can include adomed portion that contacts the recto-vaginal septum. The expandablemember 18 can be wider at a terminal end 33 opposite to where itattaches to the stabilizing body 12 (FIG. 31A), or can be narrow at itsterminal end 33 (FIG. 31B). The expandable member 18 can be curved (FIG.31C).

The expandable member 18 can be in the form of a balloon type portion.The balloon can have a permeability to allow for deflation over apre-determined range of time. Other forms of the expandable member 18can also be used. A surface of the expandable member 18 that contactsthe vagina wall can include grips 52 for stabilization. The grips 52 aresmall enough and shaped so that they do not irritate or damage thetissue, and they can also be in the form of suctions as described above.

The expandable member 18 can also provide partial, but not totalocclusion. It cannot require total or complete occlusion to preventfecal excretion. Upon occlusion, it is preferred that as much functionof the rectum is left as possible, but that the most compliant area ofthe recto-vaginal septum is engaged and only that area by the expandablemember 18. That is, the expandable member 18 should contact the rectumas low as possible to permit as much of the rectum to be functional forfecal storage, and yet it should contact the rectum high enough toprovide effective contact to result in the occlusion. This location ispreferably above the perineal body, which is bulkier and usually lesscompliant the recto-vaginal septum. Therefore, in order to provide thebest positioning of the device 10, the expandable member 18 can bemanufactured at different positions along the posterior end 16 or alongvarious portions of the stabilizing body 12 in order to fit differentanatomies. The expandable member 18 can also be manually adjustablealong the length of the posterior end 16/stabilizing body 12, which thephysician can adjust to fit a patient (FIGS. 18A-18B), with an adjustingmechanism 56. Preferably, the expandable member 18 extends from thestabilizing body 12 at a non-zero angle with respect to a line formed bythe anterior end 14 and the posterior end 16. More preferably, theexpandable member 18 contacts the rectum wall at a 45-135 degree angle.The expandable member 18 can be angularly adjustable with an angularadjustment mechanism 58 in order to ensure that it is targeting theappropriate part of an individual's anatomy, as shown in FIGS. 19A-19D.

An inflation mechanism 28 is included on the expandable member 18 forexpansion and contraction (deflation), which can be reversible orirreversible. The inflation mechanism 28 can be permanently attached tothe expandable member 18 and remain in the vagina or extend outside ofthe vagina (further described below) to expand and contract theexpandable member 18. The inflation mechanism 28 and can be in the formof a tube (FIGS. 25A-25B) that creates a leak when pulled that createsirreversible deflation. The tube can also be used with a tool 64 forwidening the tube for emptying or filling the tube. Alternatively, theinflation mechanism 28 can be removably attached and can be attachedonly when the expandable member 18 needs to be expanded or contracted.The inflation mechanism 28 can include a flange at the end attached tothe device 10, and located within the device 10, in order to prevent theinflation mechanism 28 from being pulled out of the device 10. Theinflation mechanism 28 can be manually operated, such as by pulling onthe inflation mechanism 28 to contract or expand the expandable member18 (shown in FIGS. 11C and 11D), using a hand pump, reservoir, syringe,or it can be electronically operated by a remote control outside of thebody. In this case, the expandable member 18 and device 10 includeappropriate electronics. The inflation mechanism 28 can be a single usedevice that is thrown out after use. For example, the single use devicecan be an air-filled pouch or reservoir 70 that can only be compressedonce to fill the device 10, shown in FIGS. 35A-35C, through a one-wayvalve 68. After inflation, the reservoir 70 is removed and the one-wayvalve 68 remains. Alternatively, it can be a locking syringe 72 thatonly compresses once through the one-way valve 68, shown in FIGS.36A-36C. After inflation, the syringe 72 is removed and the one-wayvalve 68 remains.

The inflation mechanism 28 can also be an electromagnetic system, shownin FIG. 29, that can be activated externally by a switch that turns onan electromagnet causing the expandable member 18 to expand or contract.For example, one electromagnet can be on the top side 32 of theexpandable member 18 and another electromagnet can be located oppositethereto on a bottom side 33, and they can be toggled between attractingeach other (contracted state) and repelling each other (expanded state).Appropriate electronics and leads can be included to operate themagnets. The inflation mechanism 28 can also be water, air, aself-curing polymer, or a material that reacts to moisture or heat foundin the vagina.

The expandable member 18 can be naturally in an expanded state and mustbe actively contracted, or alternatively, the expandable member 18 canbe naturally in a contracted state and must be actively expanded.Specific examples of the active contraction mechanisms are springsinside the expandable member 18 (further described below), an elasticmechanism attached to the expandable member 18, or an elastic material.Alternatively, the expandable member 18 can include a mechanism forexpanding automatically, such as elastics and a one-way valve forallowing air to enter as the expandable member expands. An example of anirreversibly expandable device 10 with active contraction is shown inFIGS. 26A-26B, wherein the inflation mechanism 28 is a zip-tie-likechord that can be pulled, ratcheting the expandable member 18 down.

The inflation mechanism 28 can further include a cap or a valve 34 on adistal end 36 that is accessible outside of the body, as shown in FIGS.9A-9C. By use of the cap 34, the expandable member 18 can be inflatedfully or partially prior to insertion of the device 10 in the body. Thecap 34 can be removed or actuated to deflate the expandable member 18and allow stool to pass through the rectum. To enhance deflation, thefluid in the expandable member 18 can be actively expelled by means of apump. The expandable member 18 can then be expanded again, either by amechanism as described above, or the expandable member 18 can expand onits own due to the stiffness of the material it is made from.

The expandable member 18 can include a spring 38 that self-expands theexpandable member 18, as shown in FIGS. 10A and 10B, and 11A and 11B. Inother words, the expandable member 18 can be self-expandable by variousmeans, requiring active deflation or contraction to allow fecal passage.In this embodiment, the user would not have to actively inflate orexpand the device during use. Rather, the user would actively deflate orcontract the device to allow for fecal elimination.

The inflation mechanism 28 can include a string 40 accessible to theuser outside of the body that can be pulled to collapse the spring 38and allow stool to pass. After the string 40 is released, the spring 38pushes the expandable member 18 back into an expanded state naturally.In other words, this expandable member 18 is generally in an expandedstate and must be actively contracted. The spring 38 can also work withthe cap 34 described above instead of the string 40. A tube or a wirecan also be used in place of the string 40. The spring 38 can also becontrolled by a component separate from the device 10, such as a rod, athreaded member, or a keyed member, that is insertable into the vaginafor engagement with the spring 38. Preferably, these mechanisms thatextend outside of the vagina are of minimal size so as not to causediscomfort of the user. This can include tubes that are collapsible to agenerally flat profile and can be opened with the insertion of anadditional component to aid in inflation/deflation (shown in FIGS.25A-25B).

The inflation mechanism 28 can further include a latching mechanism 60for holding the inflation mechanism 28 (preferably in the form of atube) in a retracted position inside the vagina, shown in FIGS. 23A-23C.Users can prefer the comfort of this option as opposed to allowing aninflation mechanism 28 to extend outside the vagina. The latchingmechanism 60 can include a first component towards a distal end of theinflation mechanism and a second component on the stabilizing body 12,the expandable member 18, or the inflation mechanism 28 proximate to thestabilizing body 12. The latching mechanism 60 can be a mechanical latch(such as a clip, FIG. 23C), a magnetic latch (FIG. 23B), or a hook andloop latch. The inflation mechanism 28 can be retractable into thestabilizing body 12 or the expandable member 18 when not in use (FIGS.30A-30B). The latching mechanisms 60 can also be features attached tothe inflation mechanism 28 that, based on their size and shape, areretained above the introitus. These features can also facilitate theretrieval of the inflation mechanism 28 when inflation/deflation isrequired.

The inflation mechanism 28 can further include an attachment mechanism62 towards a distal end of the inflation mechanism 28 for pulling it orthe device 10 downward, or for tucking and maintaining the inflationmechanism 28 inside the vagina. The attachment mechanism 62 can be aflexible or non-flexible ring or loop, as shown in FIGS. 24A-24B.

The inflation mechanism 28 can be external to the vagina and engage theintra-vaginal device 10 to permit the exchange of fluid with theexpandable member 18 (FIG. 28A). In this case, the inflation mechanismis preferably a syringe, or pump that interfaces with the intra-vaginaldevice 10. The inflation mechanism 28 can interface with a valve 68 orsystem of valves on the stabilizing body 12 or the expandable member 18.The stabilizing body 12 or the expandable member 18 can include amechanism 66 for directing the inflation mechanism 28 to the valve 68 orsystem of valves, such as a funnel structure (FIGS. 28C-28D), or amagnetic attraction (FIG. 28B).

The expandable member 18 can further include a supportive member 30,such as a cut silicon sheet or a molded silicon member, in order toprevent the expandable member 18 from tilting due to force from thepresence of stool in the rectum. FIGS. 6A-6D show what can happen to theexpandable member 18 with force applied thereto, i.e. the expandablemember 18 can begin to tilt upwards into the stabilizing body 12, andnot completely block the passage of stool. Therefore, a supportivemember 30 can be attached between the expandable member 18 and thestabilizing body 12 so that tilting is prevented. The supportive member30 can cover the entire surface of a top side 32 of the expandablemember 18, as in FIG. 6E, or the supportive member 30 can be only astrip covering a portion of the top side 32, as in FIG. 6F. Thesupportive member 30 can also be integrated directly in the top side 32of the expandable member 18. The supportive member 30 can also cover aportion or an entire inner space of the stabilizing body 12 (as shown inFIGS. 21A-21D). The supportive member 30 can be made of any suitablematerial that can withstand the force of the stool on the expandablemember 18 and maintain the expandable member 18 in position.

The expandable member 18 can further include reinforcements 42circumferentially around the surface, such as string, stiffer materialthan the expandable member 18 itself, or a thicker portion of the samematerial, as shown in FIG. 11E-11F. The reinforcements 42 can aid instretching the expandable member 18 in a preferential direction, i.e.,at the 45-135 degree angle to the rectum wall. The supportive member 30can also include reinforcements 42 for preventing deflection such asembedded fibers, plastic, or metal.

The expandable member 18 can also support anatomical features externalto the vaginal cavity to prevent their prolapse into the vaginal cavity.

In order to ensure a comfortable fit for users who have a more prominentcervix (FIG. 12A), the top side 32 of the expandable member 18 and/orsupportive member 30 can be bowed into the expandable member 18,accomplished by an indentation or a hole, as shown in FIGS. 12B-12C. Anysuitable amount of bowing can be used and this aspect can be designedfor a particular user by trial and error fitting, or medical imaginganalysis of the vagina.

FIGS. 17A and 17B also show the device 10 with multiple sides 20 orrails of the stabilizing body 12 extending from the anterior end 14 tothe posterior end 16 that anchor the cervix and also prevent rotationalong the length of the device 10. FIG. 17C shows that in this form, thestabilizing body 12 can be collapsed to a smaller profile for insertion,such as by pulling on the ends 14, 16 of the device 10. The springforces in the sides 20 can also cause the device 10 to spring back tothe larger profile (FIG. 17D). The device 10 can also be forced into thelarger profile, such as by a member 54 that can be pulled, pulling theends 14, 16 of the device 10 together (FIG. 17E).

Various aspects of the device 10 can also serve to support other organsaround the vagina to help alleviate symptoms of prolapse. Thestabilizing body 12 can include an anterior end 14 with other shapes,projections, or space-occupying features in order to keep the device 10stable in the vagina, but not cause lateral displacement of the vaginawalls. For example, the stabilizing body 12 can include a ring-shapedanterior end 14′, shown in FIGS. 8A-8B. The stabilizing body 12 does nothave two sides of a central portion 20 in this case but rather a singlecentral portion 20 connects the anterior end 14′ and the posterior end16. The anterior end 14″ can also be a cross-shape, or anchor shape asshown in FIGS. 8C-8D. The anterior end 14′″ can also be a multi-prongedanchor shape, as shown in FIGS. 8E-8F. The anterior end 14″″ can be asoft or spongy portion, e.g. tampon-like material, that prevents thedevice 10 from sliding out in FIG. 8G and also expands as it absorbsbody fluids such as water. The anterior end 14 can be a disc ordiaphragm that is a generally perpendicular planar body to act as a plugto keep the device 10 inside the introitus as shown in FIG. 8H-81. Thedisc 14 can be a soft material such as a compliant cushion so that itcan deform during insertion, and can also provide suction. Drainageholes 44 can be included as well as a removal mechanism 46, such as astring or soft silicon, which can extend outside of the vagina tofacilitate removal. 15. The disc 14 can include an embedded member whichcan be pulled to reversibly or irreversibly disrupt the mechanicalintegrity of the disc 14 such that the device 10 is easily removed. Theremoval mechanism 46 can be included on any embodiment as well, and canbe a ring, string, wire, flap, rod, or tube.

The anterior end 14 can be mechanisms to secure the device 10 in thevagina as well as allow for easy removal, such as a spring and tab asshown in FIG. 8J. The tab can be depressed and cause the spring to becontracted, allowing for removal of the device 10. Additionally, theanterior end 14 can be shaped to approximate the curvature of the pelvicfloor muscles it interacts with.

Another important aspect of the device 10 is that it has positionalstability and rotational stability within the vagina. The positionalstability is provided by points of contact of the device 10 with thevagina, most notably the anterior end 14 with the pubic notch and theposterior end 16 with the posterior fornix. The expandable member 18 canfurther provide stability with contact with the wall of the vagina. Itis this positional stability that allows the stabilizing body 12 to bedesigned in different shapes as long as these points of contact remain.Rotational stability is provided as well by the contact of the anteriorend 14 with the pubic symphysis and the posterior end 16 with theposterior fornix. This rotational stability limits the rotation ofdevice 10 when the expandable member 18 is expanded. Additionally,rotation around the device's anterior-posterior axis is prevented byextensions off of this axis as described above, and more specifically bya generally planar structure. Even more specifically, this rotation isprevented by the additional width of the stabilizing body 12 at eitherend of the device 10. The expandable member 18 contacts the same part ofthe vagina wall to occlude the rectum every time that the device 10 isused.

Therefore, the present disclosure provides for a stabilizing mechanismfor repeatably contacting the force applying portion 18 with a same areaof an anterior rectum wall, the force applying portion 18 being able toinhibit the ability of the rectum to expand to allow stool to passthrough. These aspects of the disclosure are critical for assuringmaximum comfort and reliability of results for the user.

The stabilizing mechanism can be longitudinal members (i.e. sides 20 andthe anterior end 14 and posterior end 16) that form a three-dimensionalstructure that can change from a smaller profile for insertion to alarger profile for stability. This ability to change the form isdescribed above with the springs 26. The longitudinal members can exerta spring force biasing them towards the larger profile. A mechanicalmechanism can be used to secure the longitudinal members in the largerprofile, such as a compression mechanism for drawing ends of thelongitudinal members close together, i.e., a string, wire, tube, chain,flexible rod, or threaded member.

An additional embodiment utilizes suction forces on a body forstabilization means to allow repeatable positioning and repeatablecontact to the recto-vaginal septum (FIGS. 16A-16E). These bodies can bedifferent shapes other than the preferred shape described herein, suchas, but not limited to, a cube, wedge, or pyramid, provided they meetthe described criteria for stabilization and force application.

In an additional embodiment, the stabilizing mechanism can be secured toa body through surgical attachments to one or more walls of the vaginaas described above. The stabilizing mechanism can also include adhesiveto secure in the body.

More generally, the device 10 can substantially maintain a single shapethat applies force to the rectum. This force can be modulated bychanging the position of the device 10 inside the vagina, or by removaland insertion of the device 10.

The present disclosure also provides for an intra-vaginal device 10including a stabilizing mechanism as described above for stabilizing thedevice 10 to prevent rotation and translation in the vagina, therebyallowing a portion of the device 10 to reversibly apply force to thesame area of the rectovaginal septum to control stool movement throughthe rectum. The importance of applying pressure on the same area of therectum has been described above.

The present disclosure provides for a method of controlling stoolmovement through the rectum, by stabilizing the intra-vaginal device 10described above and preventing rotation and translation in the vagina,reversibly applying force to the same area of the rectovaginal septumwith the device 10, and controlling stool movement through the rectum.The force can be applied with the force applying portion 18 as describedabove.

The present disclosure also provides for an intra-vaginal device 10,including a stabilizing mechanism for stabilizing the device 10 toprevent rotation and translation in the vagina in a first and secondstate, wherein when in a first state, force is not applied to therectovaginal septum (RVS) and, wherein when in a second state, force isapplied to the RVS thereby allowing a portion of the device toreversibly apply force to the same area of the rectovaginal septum tocontrol stool movement through the rectum.

The present disclosure provides for a method of controlling stoolmovement through the rectum, including the steps of stabilizing theintra-vaginal device 10 described above and preventing rotation andtranslation in the vagina when the device 10 is in a first and secondstate, wherein when in a first state, force is not applied to therectovaginal septum (RVS) and, wherein when in a second state, force isapplied to the RVS, reversibly applying force to the same area of therectovaginal septum with the device, and controlling stool movementthrough the rectum.

There can be other mechanisms used along with the device 10 in order toachieve rectal occlusion. For example, a magnet 48 can be surgicallyimplanted in the posterior rectal wall in order to interact with acorresponding magnet 48′ on the device 10, such as at the bottom of theexpanding member 18 as shown in FIG. 13A. The magnets 48, 48′ can beelectromagnets and can be externally controlled, allowing them tointeract with each other to occlude the rectum or to let stool pass.Alternatively, magnet 48′ can be simply implanted in the vagina wallopposite the posterior rectum wall without the device 10 to achieve thesame results. Also, a mass-occupying agent 50 can be injected into theposterior rectal wall, as shown in FIG. 13B, so that when combined withthe device 10, better occlusion of the rectum occurs. Preferably, themass-occupying agent 50 is directly opposite to the expanding member 18and interacts therewith. The device 10 can be used with an implantedsling that pulls the rectum anteriorly.

The present disclosure provides for a method of controlling the passageof stool in a patient, including the steps of inserting theintra-vaginal device 10 into the patient's vagina such that the anteriorend 14 rests around the pubic notch and the posterior end 16 rests inthe posterior fornix, exerting a force towards the posterior side of thevagina, preventing expansion of the patient's rectum with the force,impeding the passage of stool, and removing the force, allowing stool topass. By performing this method, the patient can use the device 10 toprevent stool from passing or allow stool to pass through the rectum.When inserting the device 10, the sides 20 can narrow by the operationof the springs 26 at the anterior end 14 and posterior end 16 for easierinsertion. Then the sides 20 return to their normal open position oncethe device 10 is positioned around the pubic notch and in the posteriorfornix. Preferably, the force applying portion 18 exerts the force andmoves the anterior wall of the rectum. As described above, the forceapplying portion 18 can be expanded manually or electronically. As theforce applying portion 18 expands, because there is slack in the vaginawalls, the force of expansion is directed against the rectum, andpassage of stool is inhibited. The force can be exerted substantiallyabove the perineal body. The prevention can be an occlusion of therectum. When it is desired that stool pass through the rectum, theexpandable member 18 is contracted (there can be recovery of theexpandable member through various mechanisms described above) and thewalls of the rectum are allowed to accommodate stool normally.

In an alternative embodiment, device 100 includes a stabilizing body 102having an anterior end 104 and a posterior end 106, the posterior end106 operatively connected to an occluding member 108 and including atoggle mechanism 110 for toggling the occluding member 108 between anocclusive and passive state. Essentially, the occluding member 108 canchange orientation between a rectally occlusive state, shown in FIG.14A, to a passive state to allow stool to pass through the rectum, shownin FIG. 14B. The device 100 is generally the same as device 10 describedabove, except that instead of expanding, the occluding member 108toggles positions. The device 100 preferably is situated in the vaginasuch that the anterior end 104 rests around the pubic notch and theposterior end 106 rests in the posterior fornix.

The toggle mechanism 110 can be any mechanism known in the art to togglepositions of the occluding member 108. For example, the toggle mechanism110 can be a hinge or a flexible joint that joins the occluding member108 to the stabilizing body 102. The toggle mechanism 110 can be atranslatable occlusive member such as a slidable occlusive member, or anocclusive member with multiple locked positions such as snap-fit lockingmechanisms. (FIG. 33C). The toggle mechanism 110 can also be a threadedmember that can be extended or retracted by engaging one or morethreads, shown in FIGS. 33A-33B. Preferably, the toggle mechanism 110includes a method of locking the occluding member 108 when occlusion isdesired and so that movement of the occluding member 108 does not occur.A latch mechanism 112 can be used to lock the occluding member 108 inthe occluding position as shown in FIGS. 14C-14D anywhere on theoccluding member 108 and stabilizing body 102, such as on a sideopposite to the toggle mechanism 110. The toggle mechanism 110 caninclude a control string 114, as shown in FIGS. 14E-14F, or any othercontrol component that extends outside of the vagina such as a wire,tube, lever, or threaded component. The control string 114 can beattached anywhere appropriate on the occluding member 108. Under tensionof the control string 114, the occlusive member 108 cannot move and islocked in place in an occluding position. When tension in the controlstring 114 is released, the occlusive member 108 is free to rotate andmoves to a passive position to let stool through the rectum. Theoccluding member 108 can have an altered or more tapered shape on a sideopposite to the toggle mechanism 110 in order to have a more comfortablefit when in the passive position, as shown in FIG. 14G. In an alternateembodiment, the intra-vaginal device can be toggle between and occludingand non-occluding state by removing the device in its entirety from thevagina.

Therefore, the present disclosure provides for a method of controllingthe passage of stool in a patient, including the steps of inserting theintra-vaginal device 100 into the patient's vagina such that theanterior end 104 rests around the pubic notch and the posterior end 106rests in the posterior fornix, toggling the occluding member 108 at theposterior end 106 to an occlusive state, preventing expansion of thepatient's rectum with the occluding member 108, impeding the passage ofstool, and toggling the occluding member 108 to a passive state,allowing stool to pass. This method is generally performed as the methoddescribed above, except that instead of expanding the expandable member18, the occluding member 108 is toggled between an occlusive state toocclude the passage of stool in the rectum and a passive state to allowthe passage of stool. The toggling step can further include shifting theoccluding member 110 to different snap-fit positions, (FIG. 33C) slidingthe occluding member 110 to different position, or engaging threadedcomponents on the occluding member 110 for moving the occluding member110. The toggling step can be performed by actuating the control string114 above, or a wire, tube, lever, or threaded component. Thesecomponents for actuation can be outside of the vagina. The toggling stepcan also include locking the occluding member 108 with the latchmechanism 112 described above. The preventing step can also includeoccluding the rectum.

In another embodiment, shown in FIGS. 15A-15D, device 200 includes astabilizing body 202 having an anterior end 204 and posterior end 206,the posterior end 206 including magnets 210 that act as a dockingmechanism for receiving an occluding member 208 having magnets 210′. Inthis device 200, the stabilizing body 202 and occluding member 208 areseparate pieces. Preferably, the stabilizing body 202 is generally asdescribed above and the same shape, with the addition of magnets 210 inthe posterior end 206 for receiving the occluding member 208. The device200 preferably is situated in the vagina such that the anterior end 204rests around the pubic notch and the posterior end 206 rests in theposterior fornix. The occluding member 208 has corresponding magnets210′ in areas that line up with the magnets 210 of the posterior end206. The occluding member 208 can be a rigid material, or it can besemi-rigid and expandable, or compliant as described above. Theoccluding member 208 can include an insertion mechanism 212 that can beused for ease of insertion into the vagina and can aid in stabilizingthe occluding member 208 within the stabilizing body 202. When in place,the insertion mechanism 212 can reach from the occluding member 208 tothe anterior end 204, as shown in FIG. 15D. The stabilizing body 202 canalternatively, or in addition to the magnets 210, include a mechanicallock 214. In this case, the occluding member 208 also includes amatching mechanical lock 214′ to secure the occluding member 208 in thestabilizing body 202. The docking mechanism can also be shape fit, i.e.the shape of the device 200 itself that allows for docking. When it isdesired to prevent the passage of stool, the occluding member 208 can beinserted (and optionally expanded) and held in place by the magnets 210,210′ and/or the mechanical lock 214, 214′. The occluding member 208 canbe adjustably docked along the length of the stabilizing body 202. Theoccluding member 208 can also cause the stabilizing body 202 to applyforce. When it is desired to let stool pass, the occluding member 208 isremoved (and optionally contracted). The occluding member 208 canfurther include mechanisms for removal, as described above, such asstring, a tube, wire, a ring, a tab, a chain, or a flexible rod. In thisembodiment, the stabilizing body 202 can be surgically implanted in thevagina and remain inside, whereas the occluding member 210 can beinserted or removed as desired, shown in FIG. 15E. In this case, theoccluding member 210 can be disposable whereas the stabilizing body 202is more of a permanent device. The present disclosure also provides forthe occluding member 210 itself for controlling the passage of stool,wherein the occluding member 210 is a body and includes a securingmechanism for securing the occluding member 210 to a dock on the device200.

Therefore, present disclosure further provides for a method ofcontrolling the passage of stool in a patient, including the steps ofinserting the stabilizing body 202 of the intra-vaginal device 200 intothe patient's vagina, inserting the occluding member 208 in the vagina,docking the occluding member 208 on the stabilizing body 202, preventingexpansion of the patient's rectum with the occluding member 208, andimpeding the passage of stool. Preferably, the anterior end 204 restsaround the pubic notch and the posterior end 206 rests in the posteriorfornix. The docking of the occluding member 208 can occur by theinteraction of the magnet.

Therefore, present disclosure further provides for a method ofcontrolling the passage of stool in a patient, including the steps ofinserting the stabilizing body 202 of the intra-vaginal device 200 intothe patient's vagina, inserting the occluding member 208 in the vagina,docking the occluding member 208 on the stabilizing body 202, preventingexpansion of the patient's rectum with the occluding member 208, andimpeding the passage of stool. Preferably, the anterior end 204 restsaround the pubic notch and the posterior end 206 rests in the posteriorfornix. The docking of the occluding member 208 can occur by theinteraction of the magnets 210, 210′ and/or the mechanical locks 214,214′ as described above. The docking step can include placing theoccluding member 208 such that it is compressed between the stabilizingbody 202 and vaginal wall. The preventing step can include occluding therectum. The method can further include the step of undocking andremoving the occluding member 208 from the vagina, allowing stool topass. Stool can be allowed to pass also by changing the position of theoccluding member 208 instead of removal.

Any part of the devices 10, 100, 200 can be disposable and made of amaterial that allows for flushing down the toilet after a single use.For example, the expandable member 18/occlusive member 108, 208 can beirreversibly deflated upon activation of a feature. For example, a bleedin the form of a tube/string 40 can be pulled which trips a valve ordetaches the tube 40 from the expandable member 18 or generally causesleakage of fluid, causing it to deflate, as shown in FIGS. 32A-32B. Thisallows the patient to pass stool and the device 10 is removed anddisposed of. Any of the mechanical parts of the expandable member 18,such as the spring 38 can be actuated to irreversible collapse. Anotherexample is the removal of the device 10 causes the stabilizing body 12to irreversibly collapse or lose structural integrity, shown in FIGS.27A-27B. The device 10, 100, 200 can be encased in an applicator, whichis inserted in the vagina and upon actuation; the device expands intoproper shape and rectal occlusion. A disposable pump (e.g. a bag filledwith an amount of air) can be included with the device 10, 100, 200,which can be squeezed after insertion and then can be torn off anddisposed of. The removal of the device 10 can also cause an irreversiblemechanical compromising of the device 10 that prevents future use.

The present disclosure also provides more generally for a deviceincluding a stabilizing body for stabilizing the device in a bodyorifice and a force applying portion for applying force to an orificewall, the stabilizing body imparting minimal tension on the walls of theorifice proximate to the force applying portion, such that the forceapplying portion can displace the orifice wall. In other words, thedevice 10 of the present disclosure is not limited to use in the vaginafor rectal occlusion, but can be made in different sizes for differentapplications throughout the body. The stabilizing body can narrowproximate to the force applying portion to minimize tension on theorifice wall. A region proximate to the force applying portion can benarrower than one or both ends of the device. The force applying portioncan reversibly apply force. The applied force can be imparted on aneighboring structure.

Therefore, the present disclosure also provides for a method ofcontrolling flow of a substance through a body orifice, by stabilizing adevice 10 and preventing rotation and translation in the body orifice,reversibly applying force to the same area of the body orifice with thedevice 10, and controlling the flow of the substance through the bodyorifice. This method can be performed as described above but it can beused in any part of the body, not just in the vagina for rectalocclusion.

One aspect of the disclosure is an intra-vaginal device for the controlof stool passage of an adult human female user, the device comprising areversibly extendable occluding portion, and an intra-vaginalstabilizing portion supporting the occluding portion, wherein thestabilizing portion is adapted to fit entirely within the user's vaginasuch that it maintains the occluding portion in contact with therecto-vaginal septum in extended and non-extended states to control thepassage of stool through the user's rectum. It should be noted thatextensions that exit the vagina, but do not provide stabilization orpositional support for the device are not intended to be excluded by ouruse of the terms entirely intravaginal and intravaginal.

FIGS. 37A and 37B illustrate an exemplary intra-vaginal device for thecontrol of stool passage. Device 100 includes occluding portion 102 andstabilizing portion 104. The occluding portion and the stabilizingportions are together, an example of a body that is sized and configuredto fit entirely within an adult human vagina. Occluding portion 102includes extendable member 103, which is adapted to be reversiblyextended between extended and non-extended states. FIG. 37A illustratesoccluding portion 102 in an extended configuration. Stabilizing portion104 is secured to occluding portion 102, and the device is sized andconfigured to stabilize the device entirely within a user's vagina whenoccluding portion 102 is in both extended and non-extended states.Device 100 is sized and configured to cause occluding portion 102 torepeatedly extend against the recto-vaginal septum and at leastpartially occlude the rectum even after repeated transitions to anon-extended state. The flattened body of the stabilizing portion 104 incomparison to the length of the occluding portion 102 (the length itextends from the stabilizing portion 104), and more specifically thedirection of expansion of the occluding portion 102, allows the deviceto minimize the stretch on surrounding vaginal tissue in order toocclude the rectum; and it keeps the device stable. The features of theflattened body, the occluding portion, and their relationship to eachother that allow for occlusion, stability, and comfort, of device 100,will be detailed throughout the disclosure.

Stabilizing portion 104 includes stabilizing body 105 that has a thin,low-profile body in comparison to occluding portion 102. Stabilizingportion 104 also includes a cushioning member 107 that is generallyadapted to reduce or minimize trauma to vaginal tissue, particularly inresponse to the extension of occluding portion 102. Cushioning member107 includes surface 108 adapted to engage vaginal tissue.

FIGS. 38A-F illustrate an exemplary intra-vaginal device for the controlof stool passage. Device 120 includes occluding portion 122 andstabilizing portion 124. Occluding portion includes extendable member123 that is adapted to be reversibly extended between extended andnon-extended states. Occluding portion 122 is in fluid communicationwith line 134, which can be used to add or remove fluid from withinoccluding portion 122, which is described in more detail below.Extendable member 123 is adapted to extend from a non-extended state toan extended state when filled with fluid (e.g., air, saline) viainflation line 134. The extension is reversed when the fluid is removedfrom occluding portion 122 via line 134. Exemplary ways to add or removefluid from an occluding portion are set forth herein. Occluding portion122 is shown in an extended configuration, and is secured, eitherdirectly or indirectly, to stabilizing portion 124.

Stabilizing portion 124 includes stabilizing body 125, which has anannular and planar configuration. Stabilizing body 125 is a transparentmaterial such that internal components of stabilizing portion 124 can bevisualized within the stabilizing body, but stabilizing body 125 neednot be a transparent material. Stabilizing portion 124 also includes astabilizing member disposed within stabilizing body 125, which in thisembodiment includes spring 121 and first and second wireforms 126 and129. Wireforms 126 and 129 are secured to respective ends of spring 121.Wireform 129 has a first end secured to spring 121 and second end 131that has a smaller radius of curvature than a portion adjacent to 131.In this embodiment end 131 is bent back on itself. Wireform 126similarly has a first end secured to spring 121 and second end 130 thatforms a portion with a smaller radius of curvature than a portionadjacent to end 130. In this embodiment end 130 is bent back on itself.This wireform structure, including portions 130 and 131, help supportoccluding portion 122 stay in a prescribed orientation and resistangular movement due to forces imposed on it by the user's body.

For clarity, FIG. 38C illustrates a top view of the stabilizing memberin isolation from the rest of device 120, illustrating spring 121 andwireforms 126 and 129. Spring 121 is secured to wireforms 126 and 129 byany number of suitable adhering techniques, such as welding, adhesivebonding and a friction fit. In some embodiments spring 121 is stainlesssteel, but can be any suitable material. The use of “spring” hereinincludes traditional springs as well materials with spring-likecharacteristics. For example, the spring can be a section of stainlesssteel that is laser cut to form a spiral pattern. In these embodimentsthe cut pattern can be varied to achieve desired properties of thespring.

In some embodiments one or more portions of the stabilizing member is anelastic polymer material. For example, the stabilizing member can be asilicone, a urethane, or other flexible material. In some embodimentsthe elastic polymer is more rigid than the stabilizing body. In someembodiments the stabilizing body is filled with the material and thenthe material is cured inside the stabilizing body.

For clarity, FIG. 38D illustrates a top view of stabilizing portion 124in isolation from the stabilizing member and occluding portion 122.Stabilizing portion 124 includes stabilizing body 125 secured tocushioning member 127 at locations 135. Stabilizing body 125 is atubular element that defines a channel in which spring 121 and endsections of wireforms 126 and 129 are disposed. In an alternateembodiment, stabilizing body 125 can be an overmolded element. Thisembodiment may further incorporate such additional features as thewireforms and spring within it. Cushioning member 127 is a section ofmaterial that is adapted to reduce trauma to vaginal tissue in thevicinity of the cushioning member 127. In this embodiment cushioningmember 127 is a solid or semi-solid material that provides flexibilityand deformability to prevent damage and discomfort to tissue adjacentthe cushioning member, described in more detail below.

In some embodiments stabilizing body 125 is a flexible material thatavoids injuring or causing discomfort to the patient. In someembodiments stabilizing body is a tubular silicone material, but couldbe made from any number of flexible and biocompatible materials. Thestabilizing member disposed therein can provide rigidity to thestabilizing portion while the stabilizing body provides a softer, moreflexible material to interface the vaginal tissue.

The ends of wireforms 126 and 129 that are secured to spring 121 arealso disposed within the ends of stabilizing body 125. Wireforms 126 and129 are disposed within the solid or semi-solid cushioning membermaterial.

In an exemplary embodiment of a method of manufacturing, ends ofwireforms 126 and 129 are secured to the ends of spring 121. Theassembled stabilizing member is advanced into one end of tubularstabilizing body 125 until spring 121 is disposed centrally withinstabilizing body 125. Wireforms 126 and 129 are placed in a mold withthe desired cushioning member shape, and the mold is filled with thecushioning member material. The mold is closed and the cushioning membermaterial cured. The wireforms are therefore embedded within cushioningmember 127. The configuration of the two cushioning member arms helpsmaintain the spring and stabilizing body 125 in the curved configurationand provides the stabilizing portion 124 with the general annularconfiguration.

In an exemplary embodiment of a method of manufacturing, the cushioningmember is formed by filling a mold with cushioning member material; thematerial is cured and removed from the mold. Wireforms 126 and 129 arebonded into the cushioning member. Spring 121 is bonded to one ofwireforms 126 or 129. One end of the tubular stabilizing body isadvanced over the bonded spring and wireform, the other end of thetubular stabilizing body is advanced over the other wireform and theassembly is adjusted such that the second wireform is inserted into thespring. The tubular stabilizing body is then bonded to the cushioningmember. The extendable portion is then bonded to the cushioning memberand the inflation tubing attached to the extendable portion.

Cushioning member 127 need not be attached to stabilizing body 125 atthe exact locations 135. They can be secured to each other closer to theposterior end of the device or closer to the anterior end of the device.Additionally, they need not be secured in the same location on bothsides. In some embodiments, the cushioning member is located in thevicinity of the occluding portion, as there can be force concentrationsin this area. In some alternate embodiments, the cushioning member canbe disposed on the portion of the device that resides closest to thecervix, even if the occluding portion is located at a different area. Inother embodiments, the stabilizing body may have a cushioning portion,or cushion portions, on one or more of: an extended portion along thestabilizing body, such as the lateral extents of the stabilizing body;or the distal portion of the stabilizing body that resides closest tothe pubic arch.

In other embodiments the stabilizing body and cushioning member areintegrally formed as a single structure and are therefore not twoseparate components attached to one another. For example, thestabilizing portion includes an integral stabilizing body and cushioningmember. A mold with the overall general shape of the entire stabilizingportion can be used to form the integral stabilizing portion. Astabilizing member, such as shown in FIG. 38C, can be formed within theintegral stabilizing portion.

In other embodiments, the cushioning member is comprised of a fluidfilled structure. This structure can be integral to, or separate from,the occluding portion. An exemplary embodiment of this is shown in FIG.67 and described in more detail below.

In some embodiments the stabilizing portion does not include astabilizing member disposed within the stabilizing body. In someembodiments only a portion of the stabilizing body includes a separatestabilizing member disposed therein. For example, in the embodiment inFIGS. 38A-F, the stabilizing member could simply be spring 121 disposedin the anterior portion of stabilizing body 125.

FIG. 38F illustrates a partially exploded side view of device 120,illustrating occluding portion 122, in an extended configuration,detached from stabilizing portion 124.

As mentioned above, if sufficient slack does not exist in the vaginalwall near the occluding portion before the occluding portion isextended, the occluding portion may not be able adequately deform thevaginal wall, which could result in suboptimal occlusion, very littleocclusion, or no occlusion at all. This is shown and described generallyin reference to FIGS. 7A-7D above.

In the embodiment in FIGS. 38A-F, the occluding portion is secured tothe stabilizing portion near the perimeter of the stabilizing portion.The lateral dimension of the stabilizing portion adjacent the occludingportion is less than the lateral dimension of the stabilizing portion ata wider portion of the stabilizing portion. In this embodiment this istrue because the stabilizing portion is annular and the occludingportion is disposed at the periphery of the annulus. The relativelateral dimensions could, however, be applicable with different shapeand configurations of both the stabilizing portion and the occludingportion. Because the lateral dimension of the stabilizing portion isrelatively smaller adjacent the occluding portion, the lateral stretchon vaginal tissue in this area when the occluding portion extendsposteriorly is reduced. FIG. 7D above generally illustrates thesufficient amount of slack that is retained adjacent the occludingportion when the device in FIGS. 38A-F is inserted and extended.Reducing the stretch in this area maintains slack in this region andallows the occluding portion to effectively extends towards the rectumand occlude or partially occlude the rectum, as is shown in FIG. 7D. Theslack can be maintained yet the stabilizing portion, at more anteriorlocations, is wide enough to be secured adjacent the inferior pubicramus.

FIGS. 39A and 39B illustrate an exemplary intra-vaginal device for thecontrol of stool passage. FIG. 39A is a top view and FIG. 39B is a sideview. Device 140 includes stabilizing portion 142 and occluding portion144. Stabilizing portion 142 includes stabilizing body 145 that does nothave an opening as in the embodiment in FIGS. 38A-F. Stabilizing body145 is secured to extendable member 143. Stabilizing body 145 is adaptedto stabilize the device within a user's vagina when the occludingportion is extended or not extended. In some embodiments substantiallythe entire anterior surface of stabilizing body 145 is a cushioningmember. Stabilizing body 145 can additionally have one or more holestherein to allow for the passage of vaginal fluid from one side of thestabilizing body to the other, as is generally described above.

FIGS. 40A and 40B illustrate (top view and side view, respectively) anexemplary intra-vaginal device for the control of stool passage. Device150 includes stabilizing portion 152 and occluding portion 154. Device150 includes cushioning body 155 and stabilizing member 153 therein,which includes the same components as the stabilizing member from theembodiment in FIGS. 38A-F. Stabilizing portion 152 does not include anopening therein.

FIG. 41 illustrates a top view of exemplary stabilizing portion 160 foran intra-vaginal device for the control of stool passage. Stabilizingportion 160 includes stabilizing body 162 secured to cushioning member164, similar to the way in which they are secured in the embodiment inFIGS. 38A-F. In this embodiment the cushioning member has a more linearsurface 163 adjacent opening 168 than does the embodiment in FIGS.38A-F. Device 160 has a generally annular configuration defining opening168, and a portion of cushioning member extends or fills in opening 168.The opening 168 can be larger or smaller than that shown in FIG. 41.

As background material for an exemplary method of use, FIG. 43 is aperspective view illustrating the bones of the pelvis of a human. 170 isthe pubic arch, 172 the public symphysis, 174 is the inferior pubicramus, 176 is the ischiopubic ramus. The “pubic arch” is also referredto herein as the “pubic notch.” The terms “inferior pubic ramus,”“ischiopubic ramus,” and “pubic notch” are used herein to generallyrefer to the location adjacent the pubic symphysis. The “pubic notch”can also describe a “nook”, or indentation, or depression formedadjacent to the pubic symphysis, anterior and superior to the introitus.

As described in more detail below, at least a portion of the stabilizingportion is stabilized by one or more of the boney structures of thepelvis, generally posterior and superior to the boney structure, inorder to stabilize the occluding portion against the recto-vaginalseptum such that it repeatedly extends against the recto-vaginal septumtowards the rectum to at least partially occlude the rectum. Herein,when referring to the boney structures, it is assumed that the softtissue and musculature surrounding the boney structure, and generallyforming the pelvic floor, are also involved in the stabilization of thedevice. In fact, it is possible for the soft tissue and musculature ofthe pelvic floor to provide most or all of the stabilization of thedevice, but since these structures are themselves supported by, or inthe same vicinity as the underlying boney structure, the boney structureis generally referred to as the anatomical feature to provide thestabilization.

FIGS. 44A-E illustrate an exemplary method of using device 120 that isshown in FIGS. 38A-F. FIG. 44A illustrates device 120 includingoccluding portion 122 in a non-extended configuration, and stabilizingportion 124. To ease in the insertion into the vagina, device 120 isadapted to be deformed into a delivery configuration, which is shown inFIGS. 44B and 44C. The device is adapted to be easily collapsed alongaxis F, which is shown in FIG. 38C. In this embodiment the device iscollapsed by folding the device along axis F. The flexibility anddeformability of spring 121 allows for the device to be collapsed alongaxis F. Additionally, the discontinuity between the ends of wireforms126 and 129 allows the stabilizing member at the proximal end ofstabilizing portion 120 to accommodate the collapsing motion along axisF. Portions 130 and 131 of wireforms 126 and 129 are shaped such thatwhen the device is folded, they aid in folding the cushioning portionand the occluding portion along axis F. It is disclosed that, in anembodiment such as FIG. 38C, portions 130 and 131, the firm component(s)that comprise the stabilizing body, has/have more area, in the proximityof the force applying portion. The firmer component is meant to refer toanything that gives the stabilizing body structural support. It wasdiscovered through clinical testing that designing the device to havemore area of the firmer component of the stabilizing body in theproximity of the occluding portion adds stability to the occludingportion during occlusion. Additionally, appropriate termination of thefirmer component inside the softer cushion or occluding portionsminimizes damage during repeated folding. The shape of sections 130 and131 of FIG. 38C demonstrate one embodiment of a termination that doesnot cut, or otherwise damage the soft portion it is embedded in aftermultiple fold cycles.

FIG. 44C shows the device collapsed into the delivery configurationwithout the user's hand. In some embodiments a separate tool can be usedto collapse the device and is used to insert the device into the vaginaso that a user need not use a hand for insertion and positioning. In thecollapsed delivery configuration, device 120 is inserted through vaginalopening 180, which is identified in FIG. 44D. Still in the deliveryconfiguration, the stabilizing portion is advanced into the vagina untilthe lateral-most portions of stabilizing portion 124 clear the inferiorpubic ramus. The forces applied to the device to deform it into thedelivery configuration are then released, and stabilizing portion 124then self-reverts, or self-expands, to the planar stabilizingconfiguration, as is shown in the stabilized position in FIG. 44D. Ascan also be seen in the superior view (i.e., the view looking down) ofFIG. 44E (only stabilizing portion 124 and boney pelvic structures areshown for clarity), the stabilizing portion is sized and configured suchthat the lateral portions (i.e., right and left) of the stabilizingportion are disposed further laterally than adjacent boney structuresuch that the boney structure provides a stabilizing support forstabilizing portion 124. Alternatively stated, the lateral span, orwidth, of the stabilizing portion, is greater than the lateral span ofthe inferior pubic ramus. Stabilizing portion is thereby secured by theboney structures of the pubic notch in a location posterior to the pubicnotch.

As stated above, the boney structures described herein are also intendedto be inclusive of the tissues and musculature attached thereto, and theinterference described which provides stabilization of the device can beresultant on these tissues and musculature as well.

FIG. 44E also illustrates how the rounded distal portion of thisembodiment provides a secure fit into the pelvic anatomy. The generallyrounded shape, being sized to fit proximal to the pubic arch, cansecurely engage the anatomy proximal to the pubic arch to preventexpulsion. More specifically, the device is sized and configured for thedistal end of the device to fit anteriorly in the notch formed by thepubic ramus 174. This can also be seen in the lateral view of FIG. 44A,where body 125 rests near boney structure 174. Additionally, this shapeevenly distributes any forces required in this area to counter anoutward expulsion, which may occur as a result of occluding portionexpansion, or stool forces on the occluding portion.

FIG. 44D also illustrates the position of anterior surface of the vagina181, cervix 182, posterior surface 183 of the vagina, rectal opening190, and rectal lumen 191, boney pubic symphysis 172, and inferior pubicramus 174. When the lateral portions of the stabilizing body are securedby the boney structure of the pubic arch, the proximal end ofstabilizing portion 124 is disposed at the proximal portion of thevaginal vault. In particular, in this embodiment, the proximal portionis disposed adjacent the cervix, or posterior fornix. In women who havehad a hysterectomy and thus not do have a posterior fornix, the proximalend of the stabilizing portion is disposed at the proximal end of thevaginal vault. As used herein, the proximal end of the vagina vault isused to describe the proximal end of the vagina, whether the patient hasa cervix or not. It should be noted that the device need not engage theextreme ends of the vagina for the same stabilization and occlusivefeatures of the device described herein to function. Some users of thedevice have more tone in the vagina to help secure the device withgreater clearance than what is depicted in FIG. 44D.

In the position shown in FIG. 44D, the stabilizing portion is stabilizedbetween the pubic notch and posterior end of the vaginal vault, and isstabilized proximal to the inferior pubic ramus.

In this position the device is stabilized by three locations ofstabilization: one on each of the lateral portions of the stabilizingportion, and one on the proximal end of the stabilizing portion. Thesethree locations generally define a stabilization plane for the device.

There are other device configurations that can effectively remain in anintra-vaginal position and control the passage of stool through therectum. Some embodiments utilize all three locations in theabove-mentioned stabilization plane, with the location in the proximalvagina sometimes being the occlusive portion itself. Some embodiments inthe disclosure herein describe entirely intra-vaginal stabilization andrectal compression via these stabilization locations and additionally atleast one other feature described herein, including: the specificdimensional and positional characteristics of the occlusive portion, thedimensions and configurations of stabilizing portions, combinations ofthe above referenced occlusive and stabilization characteristics, andcushioning portions.

In some embodiments the three-point stabilization, in conjunction withone or more other features described herein, describes an entirelyintra-vaginal device that can stably provide a compressive force to therectum via the vagina.

When the stabilizing portion is in this position, non-extended occludingportion 122 is disposed and stabilized against the recto-vaginal septum193, as shown in FIG. 44D (although it need not be in direct contactwith the tissue in the non-extended state). Cushioning member 127, whichis disposed generally on the anterior side of the vagina, andsubstantially opposite occluding portion 122, is in the posterior end ofthe vaginal vault. Cushioning member 127 includes surface 128 that isadapted to engage vaginal tissue on the anterior side of the vaginal inthe area of the proximal end of the vaginal vault. Cushioning member 127can also include lateral surfaces that are disposed to contact thelateral walls and proximal end of the vagina.

The stabilizing portion is also sized and configured such that theoccluding portion is positioned posterior to perineal body 185,identified with lines. Through human clinical testing, it was moredifficult to obtain intravaginal rectal occlusion through tissuedeflection in the area of the perineal body than in the area proximal tothe perineal body. This result was unanticipated because the rectalcanal is narrower in the region of the perineal body. Users also feltgreater discomfort when force was applied to the perineal body ascompared to proximal to the perineal body. In this figure, thespecificity of the stabilizing and localizing features of the device areapparent: the device is sized to fit stably within the described pelvicanatomy to maintain the occlusive portion in the described optimum areafor occlusion.

Once device 120 is stabilized in the position shown in FIG. 44D,occluding portion 122 is extended to an extended configuration as shownin FIG. 44F by inflating it with a fluid via line 134. Upon extension,occluding portion 122 pushes against the recto-vaginal septum 193 in thedirection of the rectum 191, deflecting the recto-vaginal septum 193 andoccluding rectum 191. Occluding portion 122 is disposed against therecto-vaginal septum 193 posterior to perineal body 185. Less force isrequired to deflect the septum into the rectum posterior to the perinealbody, and the user is less likely to experience discomfort. Bystabilizing the device such that the occluding portion is this deep intothe vagina, extension of the occluding portion brings the two sides ofthe rectum together (i.e., it extends in a direction that is moreclosely perpendicular to the longitudinal axis of the rectum). In theoccluded configuration, the two sides of the rectum are moved closer toone another, occluding the rectum, and preventing the passage of stool.

The “occluding portion” as described herein can also be considered thematerial interface that presses against the rectovaginal septum, whilethe extending portion is the mechanism (e.g. balloon, mechanicalextension, etc.) that creates the displacement of the materialinterface. While the occluding portion and the mechanism can be the samestructure (e.g. a balloon), they need not be. For example, an occludingportion can be extended on a free end of a cantilevered arm, wherein theangle of the cantilevered arm (and thus the displacement of theoccluding member) is adjusted by an expandable element on the side ofthe arm opposite the occluding portion. Furthermore, the term“extendable portion” is meant to refer to a portion such that when it isextended, protrudes into the rectum, and when it is not extended, doesnot protrude as much into the rectum. The portion may or may not beextendable itself, so long as it can vary its amount of protrusion intothe rectum.

When a user wishes to deform the occluding portion back towards thenon-extended state shown in FIG. 44D, the fluid is removed from theoccluding portion via line 134, deforming the occluding portion to thenon-occluded state. In this state the stool, which may be stool that hasaccumulated in the rectum, is allowed to pass. One of the advantages ofthe device is that even in the non-occluded state shown in FIG. 44D, thedevice remains stabilized in the vagina in the orientation shown in FIG.44D, with the occluding portion positioned adjacent the septum so thatit can expand in the same manner and same direction as shown in FIG.44F. This allows the device to repeatedly extend in the desireddirection to properly occlude each and every time the user expands theoccluding portion. Some of the prior art attempts do not describe adevice that provides for intra-vaginal stabilization via a separatestabilizing portion when the occluding portion is in the non-occludedconfiguration. The prior art devices are free to re-orient themselveswithin the vagina. Unfortunately, if the prior art devices havere-oriented themselves, when the user re-expands the prior art occludingportion, the occluding portion can extend is a non-desired direction,perhaps not even towards the rectum. This is unacceptable for a devicethat is intended to remain in a stable position and be repeatedlyextended and collapsed.

FIG. 45 shows an inferior and slightly anterior view of FIG. 44F, withdevice 120 positioned within the vagina. The device is shown with solidlines even though the device (with the exception of line 134) isdisposed within the vagina. Line 134 extends through vaginal opening180, and anus 194 is also shown. Stabilizing portion 124 is shownproximal to inferior pubic ramus 174. Perineal body 185 is seen throughvaginal opening 180, distal to extended occluding portion 122, which isextended down towards the rectum.

In some patients, when the occluding portion is in the occluded state,reaction forces are applied from the vagina and surrounding pelvicstructures on the occluding portion that can result in the devicerotating and/or translating to undesired locations or positions withinthe vagina. Particularly, the occluding portion can be moved out ofposition, preventing it from repeatedly being extended in a desiredlocation to occlude the rectum. To keep the occluding portion disposedagainst the recto-vaginal septum, the device should be able to withstandthese reaction forces without substantially rotating or translating.That is, the device should be adapted to maintain its orientation. Theremay be some minor, temporary rotation or translation, but as long as theoccluding portion is stabilized to be able to repeatedly apply forceagainst the septum towards the rectum, occlusion can occur. For example,if a user bears down, the device may rotate or translate very slightly,but it is still maintains the same orientation.

A device structure that does not comprise a portion or portions thatprotrude or extend towards the anterior wall generally, or relative toother portions, will distribute the reaction force of the occludingmember without pushing into the anterior wall of the vagina to causediscomfort for the user. In other words a device that is configured tonot press into the anterior wall will cause less comfort for the user.The anterior portion of the vagina is susceptible to discomfort due todistension, especially the medial area, which is adjacent the bladder. Astructure that is uneven or protruding relative to other portions on theanterior side might tend to create localized pressures and morediscomfort, especially when the device is subject to forces pushingtowards the anterior vaginal wall. Previous attempts have not describeda device for bowel control with an anterior-facing side that is designedto distribute forces as described above.

FIG. 46 illustrates device 120 with occluding portion 122 in an extendedconfiguration within a user's vagina. Stabilizing portion 124 is shownengaging anterior vaginal wall 181, and an exemplary user's vaginal wallis shown being free from distention imposed by the device, and a medialsection of the anterior vaginal wall is depicted as free to occupy thespace within the annulus of the device. While the anatomy depicted inthis figure shows a pronounced bulge in the medial section, this is notnecessarily representative of all users' anatomy. This figure isdepicted to highlight the effect of the annular configuration ofstabilizing portion 124 being adapted to distribute the reaction forceevenly in response to the extension of occluding portion 122. Anembodiment that is not necessarily an annular structure, but isgenerally uniform on the anterior side and not protruding significantlytowards the anterior wall, will distribute the force from the occludingportion such that the anterior wall of the vagina is not undulydistended. For example, this can be a solid stabilizing body that isgenerally planar (the orientation of the plane being roughly defined asbeing perpendicular to the direction of force application), similar tothe device of FIG. 39A. In this example, the lateral span of thestabilizing body further helps distribute the force evenly. An alternateexample is shown in FIG. 54, which would also isolate forces around atleast the medial portion of a user's anterior vaginal wall.

FIG. 46 also shows cushioning member 127 being pressed up against cervix182 in response to extension of the occluding member 122. The relativesoftness and deformability of cushioning member 127 helps reduce traumato cervix 182 (or to a vaginal cuff if the cervix has been removed). Inthis embodiment, cushioning member 127 provides a cushioning effect insubstantially the opposite direction to the direction of extension. Thedashed lines with arrows indicate the general directions of extension ofoccluding portion 124, and the generally opposite direction in whichcushioning member 127 provides cushioning in the area of the cervix or avaginal cuff. It should be noted that the cushioning features describedherein can also extend a distance along the sides of the occludingportion as well as along the stabilizing body. It should be noted that acushioned portion could also comprise a larger curvature of radius ofthe device, especially in the area of the cervix, in order to reducetrauma.

The cushioning member is a portion of the stabilizing portion thatapplies a great deal of the reaction force onto the vagina in responseto the extension of the occluding portion. By making it softer and moredeformable, the user is less likely to experience bruising or discomfortin that area. The cushioning member has a generally curved surface thatis adapted deform as needed to minimize trauma.

In some embodiments the cushioning member is generally more flexiblethat other portions of the stabilizing portion. For example, in theembodiment shown in FIGS. 38A-F, the cushioning member is more flexiblethan the distal portion of the stabilizing portion.

In some embodiments the cushioning member is a solid or semi-solidmaterial. In some embodiments it is solid body of material comprising apocket or pockets that are filled with a gel or gel-like material toincrease the cushioning. In some specific embodiments the material is asoft silicone with a durometer of less than about 10 A.

The cushioning member, in some embodiments, comprises an outer layerfilled with a more viscous material inside the outer layer. For example,the cushioning member can have a soft silicone outer shell filled with asilicone gel inside. Increasing the contact area of the cushioningmember can reduce the trauma to vaginal tissue.

The cushioning member should be easily collapsible or foldable to adelivery configuration. Additionally, the stabilizing device has to haveenough overall stiffness to be stabilized in the vagina. The cushiontherefore may have to be able to transition to a stiffer anteriorsection of the stabilizing portion. For example, in the embodiment inFIGS. 38-F, the anterior portion of the stabilizing portion is morerigid than the cushioning member. This allows the cushioning member toprotect the vaginal tissue near the occluding portion, but the stifferanterior portion can keep the device stabilized in the vagina and keepthe occluding portion stabilized against the septum. Alternatively, asstated above, the entire stabilizing body can act as a cushioningelement.

In the embodiments in FIGS. 38A-F, the cushion contains the relativelymore rigid stabilizing wireforms therein, which fixes the location andextension angle of the occluding portion with respect to the stabilizingportion. This also prevents deflection of the occluding portion into theannular space of the device when there are forces on the device, such asforces from stool. The described wireform shape adjacent the cushion canalso aid in folding the cushion when the device is folded for insertion.

While the cushioning member has been primarily described in relation tothe figures identified above, such a cushioning member is alsoapplicable to other embodiments described herein, and generally to anyintra-vaginal device that can apply force to portions of the vagina,resulting in transferred forces to other portions of the vagina.Additionally, the cushion embodiments described herein, especially asrelated to their general structure, can be adapted to be applied toother static intra-vaginal devices as well, as even these devices mayhave certain points of contact with the vaginal wall that require betterforce distribution. Specifically, a cushion can be added to the proximalportion of any intravaginal device in order to prevent bruising ortissue damage to the cervical region.

FIG. 47 illustrates how, in some patient's, stabilizing portion 124 isadapted to stabilize the device in response to forces applied to theoccluding portion 124 when occluding portion 124 is extended. Asoccluding portion 122 is extended, exemplary reaction force 199 isapplied on occluding portion 124 from vaginal tissue. Occluding portion122 may tend to rotate in the direction of circular arrow in response toforce 199. Stabilizing portion 124, however, is sized and configured toengage with anterior vaginal wall 181 and posterior vaginal wall 183 andtherefore prevent rotation of the stabilizing portion 124 within thevagina. By preventing stabilizing portion 124 from rotating andtranslating, occluding portion 124 is stably maintained in the properposition against the recto-vaginal septum. In this manner the device canbe reversibly extended, and each time the occluding portion 124 isextended it will extend against the recto-vaginal septum above theperineal body in the direction of the rectum to occlude the rectum. Thisapplication discloses the occluding portion configured to be located onthe center line of the lateral span of the stabilizing body. FIG. 47represents illustrative forces and is not intended to describe forcesthat occur in every patient, or even most patients. FIG. 47 merelyillustrates how the device is sized and configured to be stabilized inresponse to the occluding portion being extended, or another externalforce acting upon it.

FIGS. 48A-B illustrate dimensions of exemplary device 200. Device 200includes stabilizing portion 204 and occluding portion 202. FIG. 48A isa posterior view of the device illustrating the width of stabilizingportion “WISP”. The WSP is also referred to herein as the “lateral span”of the stabilizing portion. In either case, the stabilizing body neednot have a solid mass of material spanning the width. For example, aring shaped device has a lateral span, even though the ring defines anopening therein. The WSP general refers to the greatest lateraldimension of the stabilizing portion in either an anterior or posteriorview. FIG. 48A also illustrates the width of the occluding portion WOP.Similarly, the WOP generally designates the greatest lateral span of theoccluding portion. It can refer to the occluding portion in eitherextended or non-extended configurations. FIG. 48A illustrates the WOP inan extended configuration.

In some embodiments, the WOP is less wide than WSP. This provides a morestable configuration of the device when the occluding portion isextended. For example, FIG. 47 and the description thereof provide anexample of how the device is more stable when the occluding portion isextended. For a WSP that is appropriately sized for stability, a WOP ofa smaller dimension allows the occluding portion to press into therectum to an effective depth, while a patient remains comfortable. Eventhough a WOP equal or greater than the WSP could fit with the dimensionsof the surrounding anatomy, it was discovered that reducing the WOP, inrelation to the WSP, increased vaginal slack in such a way that allowedfor more effective posterior compression of the rectum through thevagina, while maintaining stability. Additionally, the stretch caused byrectal compression when the WOP is equal or greater to the WSP createsdiscomfort for the user and increases the risk of adverse events.Previous attempts have not described an occluding portion that is lessin width than the stabilizing portion in order to produce comfortableand effective rectal compression.

The dimensions and ratios described below apply to a given aspect of adevice on average and aren't meant to be limited by localized departuresfrom these dimensions. For example, a device that had a certainthickness, and had a small protrusion that was greater than thisthickness, would still be considered to have a general thickness in theregion without the protrusion.

FIG. 48B illustrates the length of the stabilizing portion “L,” thethickness “T” of the stabilizing portion, the length of the occludingportion “LO”, and the extension length EL of the occluding portion.These dimensions are in a side view of the device.

In some embodiments, the thickness “T” is no greater than about 2.5 cm.In another embodiment, the thickness “T” is no greater than about 1.75cm, and in some embodiments, the thickness “T” is about 5 mm-about 1.5cm. Testing demonstrated that the thickness of the stabilizing portionplayed an important role in device function. Reducing the thickness ofthe stabilizing portion increased the slack in the surrounding vaginaltissue, which turned out to increase the ability of the occludingportion to compress the rectum. These thickness values are smaller thanprevious attempts at intra-vaginal bowel control devices, some of whichdescribe a tubular, bulkier body.

In some embodiments, the ratio of the thickness “T” to WSP is no greaterthan about ½. In some embodiments the ratio of the thickness “T” to WSPis no greater than about ⅓. In some embodiments the ratio of thickness“T” to WSP ranges from about ¼-about 1/10. A device with these ratioswon't take up too much volume in the vagina, thereby allowing for slackin the vaginal tissue for rectal compression, but has a width dimensionthat is capable of providing sufficient stabilization in the vagina towithstand the reaction force caused by the occluding portion.

In some embodiments, the ratio of the greatest length of the stabilizingbody to the WSP is no greater than about 2. In some embodiments, theratio of the greatest length of the stabilizing body to the WSP is nogreater than about 1.25. In some embodiments, the ratio of the greatestlength of the stabilizing body to the WSP is no greater than about 1.1.In some embodiments, the ratio of the greatest length of the stabilizingbody to the WSP is no less than about ½. In some embodiments, the ratioof the greatest length of the stabilizing body to the WSP is no lessthan about ¾. Clinical testing demonstrated that a vaginal bowel controldevice with these ratios had proper stability to withstand rotationduring occluding and non-occluding states.

In some embodiments, the range of effective lengths for the stabilizingbody is about 30 mm-about 100 mm. In some embodiments, the range ofeffective lengths for the stabilizing body is about 44 mm-about 83 mm.In some embodiments the range of effective WSP's is about 30 mm-about100 mm. In some embodiments the range of effective WSP's is about 44mm-about 76 mm.

In some embodiments, the volume of the occlusive portion is betweenabout 60 cc and about 10 cc in an extended state. In some embodiments,the volume of the occlusive portion is between a range of about 15 ccand about 50 cc in an extended state. Testing revealed that devices withocclusive portions of these volumes provided an effective amount ofocclusion for treating fecal incontinence, while also being comfortableand safe for patient use.

In some embodiments the length of the occlusive portion (inclusive ofthe stabilizing body and in the direction towards the rectum) is about20 mm-about 80 mm. In some embodiments, the length of the occlusiveportion (inclusive of the stabilizing body) is about 30 mm-about 70 mm.Clinical testing determined a length that extended far enough into therectum to provide bowel control, but not too far to put an uncomfortableand unsafe amount of pressure on the rectum and vaginal walls. In someembodiments, the WOP is about 20 mm-about 60 mm. In more preferredembodiment, the WOP is about 30-about 60 mm. It was discovered that thiswidth was not too wide so as to reduce the slack in the vaginal tissueand inhibit rectal compression. At the same time, this range was wideenough to create an effective amount of occlusion for bowel control.

In some embodiments, the ratio of the thickness “T” of the stabilizingportion to the extension length “EL” is no greater than about ⅔. Morepreferably, the ratio of the thickness “T” to the extension length “EL”is no greater than about ½. In some embodiments the ratio of thethickness “T” to the extension length “EL” is within the range of about0.16-about 0.4. It was an important discovery through clinical testingthat the stabilizing body should be thin in comparison to the length ofthe occluding portion. This allows the stabilizing body to take up lessslack in the vaginal tissue, which allows the rectal compression portionto expand posteriorly with less stretch on the tissue and discomfort.Additionally, this ratio allows for the device to collapse to a smallenough thickness to allow stool to pass normally in the non-occludingstate, since the thickness of the stabilizing body is only a smallportion of the total dimension of T plus EL.

In some embodiments, the maximum thickness of thickness “T” plus thethickness of the un-extended occlusive member is no greater than about3.5 cm. In some embodiments the maximum thickness of thickness “T” plusthe thickness of the un-extended occlusive member is no greater thanabout 2.5 cm. In some embodiments the maximum thickness of thickness “T”plus the thickness of the un-extended occlusive member is no greaterthan about 1.5 cm. In some embodiments the maximum thickness ofthickness “T” plus the thickness of the un-extended occlusive member isin a range from about 0.5 cm to about 1.5 cm. These exemplary combinedthicknesses provide a device with dimensions such that don't occupy toogreat a volume within the vagina, and allow the occluding portion toeffectively be collapsed without the rectum being occluded.

In some embodiments, the ratio of the thickness “T” plus the thicknessof the un-extended occlusive member to the thickness “T” plus theextended length of the occlusive member (“EL”) is no greater than about0.75. In some embodiments the ratio of the thickness of thickness “T”plus the thickness of the un-extended occlusive member to the thickness“T” plus the extended length of the occlusive member (“EL”) is nogreater than about 0.5. In some embodiments the ratio of the thicknessof thickness “T” plus the thickness of the un-extended occlusive memberto the thickness “T” plus the extended length of the occlusive member(“EL”) is in the range from about 0.25-about 0.4.

In some embodiments, the ratio of WOP to WSP is less than 1. In someembodiments, the ratio of WOP to WSP is in the range of about 0.4 toabout 0.9.

In some embodiments, the occlusive portion is located more than 2 cmfrom the distal end of the device. In a more preferred embodiment, theocclusive portion is located on the proximal half of the stabilizingportion. Through human clinical testing, it was more difficult to obtainintravaginal rectal occlusion with the same posterior force applicationin the area of the perineal body than in the area proximal to theperineal body. This result was unanticipated because the rectal canal isnarrower in the region of the perineal body. Users also felt greaterdiscomfort when force was applied to the perineal body as compared toproximal to the perineal body. Locating the occluding portion at least 2cm from the distal portion of the stabilizing body, and more preferablyon the proximal half of the device, configures it to compress proximalto the perineal body.

In a preferred embodiment, the occlusive portion compresses the rectumgreater than about 3 cm proximal to the introitus. This configurationallows the occlusive portion to press proximal to the perineal body.

Clinical testing revealed a range of pressures internal to the deviceand applied to the rectovaginal septum that were optimal for occludingthe rectum in order to prevent stool leakage, while at the same time notcausing discomfort or adverse events such as tissue necrosis. In someembodiments, the occlusive portion is inflated to a pressure of lessthan about 200 mmHg. In some embodiments, the occlusive portion isinflated to a pressure between about 40 mmHg and about 150 mmHg. Inanother exemplary embodiment, the occlusive portion is inflated to apressure between 60 mmHg and 120 mmHg.

In some embodiments, the occlusive portion applies a pressure of lessthan 200 mmHg to the rectovaginal septum in an extended state. In a morepreferred embodiment, the occlusive portion applies a pressure betweenabout 40 mmHg and about 150 mmHg to the rectovaginal septum in anextended state. In some embodiments, the occlusive portion applies apressure in the range of 60 mmHg to 120 mmHg to the rectovaginal septumin an extended state.

The occlusive portion preferably reaches the dimensions stated above atpressures of about 40-about 150 mmHg.

A preferred embodiment is sized and configured such that, when placedin-situ and inflated to a pressure between about 60-about 120 mmHg, theextension length (“EL”) of the extended occlusive portion is at least90% of its dimension when inflated ex-situ to the same pressure. Thatis, the stabilization of the device has not created additional tensionin the vagina such that the occluding portion is inhibited by therectovaginal septum from substantially reaching its full extension for agiven pressure. This is important because increasing pressure when theocclusive portion is restrained by the anatomy from reaching fullextension increases the force transferred to the rectovaginal septum,thereby putting additional strain on the tissue.

In a preferred embodiment, the occlusive portion extends at an angle ofabout 45-about 135 degrees from the substantially longitudinal axis ofthe stabilizing portion. More specifically, the stabilizing body forms aflat, planar surface that is 45-135 degrees from the direction ofexpansion of the occluding portion. This near-perpendicular angle allowsmaximum potential occlusion depth of an occluding member of a givensize. This is important because the greater the distance traveled by theoccluding member, the thinner the stabilizing portion has to be, whichincreases slack in the vaginal tissue for increased rectal occlusion andstability and allows for freer stool passage when not in an occludingstate. Additionally, configuring the device with the angle of extensionnear perpendicular reduces the tendency for the device to translateinside the vagina upon expansion.

In a preferred embodiment, the ratio of the cross-sectional area of theoccluding portion (taking the cross-sectional cut with a plane formed bythe longitudinal and lateral axes) to the area within the perimeter ofthe stabilizing body is less than about 0.8. This allows the reactionforce from the rectal occlusion to be distributed on a larger perimeterof tissue on the anterior side, increasing comfort.

In a preferred embodiment, the occlusive portion has a cross sectionalarea (taking the cross-sectional cut with a plane formed by the lateraland anterior-posterior axes) in the range from about 5.5 cm² to about 36cm². In another exemplary embodiment, the occlusive portion has a crosssectional area (taking the cross-sectional cut with a plane formed bythe lateral and anterior-posterior axes) in the range from about 6 cm²to about 25 cm².

In a preferred embodiment, the stabilizing body spans a cross sectionalarea (in the plane of the stabilizing body) in the range of about 12cm²-about 50 cm². One aspect of the disclosure is a method of applying aforce, or pressing, on the recto-vaginal septum in an area that is about12 cm²-about 50 cm².

In a preferred embodiment, the volume of the device in an un-extendedstate is less than about 60% of the volume of the extended occludingportion.

The width, area or volume of the stabilizing portion can be reduced inproximity to the occluding portion in order to further make availablethe vaginal tissue to be utilized for rectal occlusion.

It should be noted that while preferred numerical ranges are providedherein, it may be possible to deviate outside of these ranges andcompensate for the variation in other manners.

As shown in FIG. 47, the width of the stabilizing portion helps keep thestabilizing portion from pushing up into the anterior wall of the vaginawhen the occluding portion is extended.

A bulky intravaginal rectal occluder may not be as stable, and may takeup too much volume, making it difficult to manipulate the vaginal tissuetowards the rectum. It has been observed through testing that volumeappears to be especially important proximal to the perineal body wherethe occluding portion is adapted to extend. The occluding portion shouldbe sized and configured to allow at least some stool passage whennon-extended. The prior art attempts have described devices that occupyvolumes that are greater than the devices described herein

One of the deficiencies in prior art attempts is that the occludingportions are also used to secure the device. It was discovered inApplicants' testing that an intra-vaginal device where securing relieson expansion is inherently unstable when the device is unexpanded. Itwas further discovered that when such devices transition fromnon-extended to extended states, their positioning and directionality isvariable and unpredictable. This is especially problematic if the goalis to use the vaginal device to apply a directed force to the rectum.For one, if the device is inserted in an unextended state, it makes itdifficult to reliably extend to apply a force in the right location.Additionally, throughout the course of use, patients may wish todeflate, but not remove, the device for defecation or other activitieswhen they feel active bowel control is not needed. In these cases, as isthe case initially, the instability upon deflation would make itdifficult to re-extend in the right position. Prior art attempts fail toprovide intra-vaginal stabilization that does not rely on expansion ofthe device.

Another drawback to the stability of prior art attempts is that some aretubular devices, more specifically defined as generally cylindrical.Applicants' testing has revealed that this type of shape does not stablyrest in the vagina, especially if force is applied towards therecto-vaginal septum, as it tends to rotate within the vagina. Thedevices described herein do not suffer from this deficiency.

In addition to the dimensions described herein, in some embodiments thestabilizing portion has a planar configuration. Testing also revealedeffective thickness relative to lateral span of the stabilizing portionto allow proper posterior expansion but at the same time provide foradequate stabilization. Some previous attempts in this area includedevices with shapes that are generally 3-dimensional or cylindrical-typeshapes. These shapes occupy a great deal of volume in the vagina, anddon't lend themselves towards indexing in a given orientation.

As shown in FIG. 48A, the stabilizing portion is wider than it is thick.The width helps maintain orientation and the thickness provides a devicethat doesn't occupy too much volume, leaving the rectovaginal septumeasier to manipulate.

A stabilizing portion that does not have a truly planar configurationcan still provide sufficient stabilization. Embodiments below illustratethis concept. Those alternative embodiments, however, have lateralportions that stabilize against boney structure and can be stabilized ata location proximal to the two lateral stabilization locations.Additionally, in these alternative embodiments the stabilizing portionis wider than it is thick, particularly in the lateral portions wherethey are adapted to be stabilized by the boney pelvis structure. Inaddition, these alternative embodiments preferably don't occupy arelatively large volume over the perineal body when non-extended.

Another deficiency of prior art attempts is that they fail to describean efficient force transfer from the vagina to the rectum. Applicants'experimentation has revealed the importance of the availability ofredundant vaginal tissue to maintain force on the rectum. If a device isnot designed to allow redundancy (or slack) in the vaginal wall in thearea where the force is transmitted to the rectum, then the tension inthe wall makes it difficult to transfer the force posteriorly towardsthe rectum. Prior art attempts fail to describe a device that providessufficient slack.

The occluding portions of the devices herein are adapted to bereversibly extended to allow for reversible occlusion of the user'srectum to control the passage of stool. In some embodiments theoccluding portion is adapted to be inflatable with a fluid such that itexpands when the fluid is advanced into the occluding portion. In someembodiments the occluding portion can include an inflatable chamber incommunication with an external fluid source adapted to fill the chamberwith the fluid. For example, the occluding portion can comprise achamber formed of a single layer of material, or the chamber cancomprise more than one layer of material. In some embodiments one ormore layers of the inflatable chamber can be an inelastic or an elasticmaterial.

In some embodiments the stabilizing portion is also inflatable, and canbe in fluid communication with the occluding portion or not. There canbe a separate mechanism to inflate and deflate the stabilizing portion.If the stabilizing portion and occluding portion are in fluidcommunication, the stabilizing portion and the occluding portion can befilled with a line connected to the occluding portion or the stabilizingportion.

FIG. 49 illustrates an exemplary intra-vaginal device 300 adapted forthe control of stool passage. Device 300 includes stabilizing portion304 and occluding portion 302. Occluding portion 302 includes outerlayer 308 and inner layer 310 disposed within outer layer 308. Innerlayer 310 defines chamber 312. Fluid line 306 is in communication withchamber 312. Chamber 312 is not in fluid communication with the spaceoutside of inner layer 310. In this embodiment inner layer 310 is notsecured to outer layer 308, and as such the inner layer is “floating”within the outer layer. The layers can also be secured to each other.However, there are advantages to not securing the layers. One example isthe ability of the layers to move with respect to each other. This isparticularly important if the layers have different material propertiessuch as elasticity, or are sized differently. When the two layersrespond to inflation or deflation differently, it is helpful to allowmotion between the two layers. For example, if the outer layer stretcheswith pressure, and the inner layer stretches less, the balloon structureformed by the combination of the two layers can still expand withpressure as long as the inner layer has sufficient folds to allow it toaccommodate a larger volume as provided by the stretching of the outerlayer. In this case, there will be at least some relative motion betweenthe two layers.

It may be desirable to have an inner layer in the occluding portion, asin the embodiment in FIG. 49. If the fill media is air, or other gas,and the outer layer has a relatively high permeability rate to air orthe gas, then the inflation chamber may not be able to maintain adesired pressure/volume for as long as desired without an inner layer.Rather than have the gas disposed directly within outer layer 308, innerlayer 310, incorporated into the occluding portion 302, is disposedwithin outer layer 308, and the line 306 is in direct fluidcommunication with the inner chamber 312.

In an exemplary embodiment of manufacturing, the inner chamber can beformed by fusing two sheets of polyurethane together in a pattern, suchas a circle, that will inflate to form a 3-dimensional shape when fluidis introduced between the layers, within the fused pattern. To thisdouble-walled structure, a tube can be bonded by any typical means ofadhesion or heat sealing, such that the tube allows the introduction offluid between the fused layers. The double-walled inflatable portion(the inner chamber) can then be covered by the outer layer, by dipmolding, coating, or by pre-forming an outer enclosure of the desiredmaterial (e.g. silicone) with at least a portion open to allow insertionof the inner chamber, inserting the inner chamber inside the outerenclosure, and sealing the outer enclosure so that the inner chamber issealed within. Accommodation for the inflation tube can be createdbefore or after the covering of the inner chamber with the outerchamber. In a preferred embodiment, this double-layered assembly canthen be bonded to the stabilizing portion of the device by any typicalmeans of adhesion.

Air is one option for the fill media and is a very convenient way forapplying force. It is sanitary, and allows for some compliance, evenwith a non-compliant balloon material. In some embodiments one or morechambers in the occluding portion includes a silicone material. Siliconeprovides the following advantage for an intra-vaginal rectal occlude: itis soft, elastic, bio-compatible and has a long history of intra-vaginaluse. Silicone is, however, very permeable to air, and a silicone chamberinflated with air could lose effectiveness when the user desires to keepan inflatable occluding portion extended. For example, in some cases asilicone chamber filled with air can lose effectiveness in about 4hours, which may limit the utility of the device. The time in which ittakes to lose effectiveness is, however, dependent of the thickness ofthe silicone material, the volume of air in the occluding portion, andother factors. The disclosure describes air within silicone, butmaterials other than silicone can have the same drawbacks when used witha variety of fill media. Incorporating an inner layer can be beneficialin a variety of material combinations.

In the embodiment of FIG. 49, air is the fill medium and is pumped intochamber 312 defined by inner layer 310. Outer layer 308 is a siliconematerial, which enables the tissue contacting portions of the device tomaintain the exemplary advantages of being silicone. The fluid is,however, less permeable through inner layer 310 than outer layer 308. Inthis exemplary embodiment inner layer 310 is less permeable to air thanthe silicone outer layer 308. This allows the tissue contacting surfacesto be silicone (or other similar biocompatible material), but increasesthe length of time that the occluding portion can maintain pressure andvolume.

In some embodiments the inner layer is thinner than the outer layer. Thecombined thickness and flexibility of the outer layer and the innerlayer should result in a foldability for the occluding portion that isacceptable.

In some embodiments rather than incorporating an inner layer, thethickness of the outer layer can be increased to provide the device witha permeability that is acceptable.

In some embodiments the outer layer can be coated on the outer or innersurface to reduce the permeability of the layer. For example, a siliconematerial can be coated with parylene. If the outer layer has elasticcharacteristics, however, the coating may not stretch as much as theouter layer, which can result in gaps in the coating which renders theouter layer permeable. If the outer layer is a non-elastic orsubstantially non-elastic material, however, coating the layer mayresult with the desired permeability. Other potential ways to limit theexpansion of the outer layer include, for example, using a material witha relatively high durometer, or incorporating scaffolding or other typesof reinforcements into the outer layer.

Exemplary advantages of some of the devices herein are that theextendable member of the occluding portion is a soft, relatively elasticballoon, and is biocompatible. Providing an inner layer that is lesspermeable to air allows the outer layer to be a silicone material andhave these desired characteristics.

One of the other characteristics of some of the occluding portionsherein is that they are relatively compliant, which reduces thelikelihood of trauma to the vaginal tissue, and allows some deformationwhen the patient may assume different positions (e.g., bearing downversus standing upright). In the exemplary embodiment shown in FIGS.38A-F, the occluding portion includes an inner and outer layer asillustrated in FIG. 49. In a specific embodiment the extendable member,including the inner and outer layers, has a wall thickness between about0.005″-0.040.″ Some of the compliance is achieved by having a relativelythin walled occluding portion. Some of the compliance is also achievedby the elasticity of at least one of layers of the occluding portion.Additionally, in this embodiment the fill medium is air, which iscompressible. In a specific embodiment, the inner layer comprises aballoon (herein referred to as an “inner balloon”) that is not in fluidcommunication with the space between the inner layer and the outerlayer. The outer layer comprises a balloon (herein referred to as an“outer balloon”) inside which is the inner balloon. This inner balloonhas a potential volume larger than the nominal (neutral pressure) volumeof the outer balloon. The compliance of the outer balloon thereforelimits the expansion of the inner balloon. In this way, even if theinner balloon is of a relatively inelastic or non-compliant material,the combined configuration allows for overall compliance, provided bythe elasticity or compliance of the outer balloon and the slack orexcess material in the inner balloon. In a specific embodiment the innerlayer is polyurethane, with a durometer of about 80 A, and a thicknessof about 0.003″. The outer layer is silicone, with a durometer of about60 A, and a thickness of about 0.015″.

In some embodiments the outer layer is a soft biocompatible elastomericmaterial. For example, the outer layer can be silicone with a durometerbetween about 30 and about 60 A, and have a thickness between about0.005″ and about 0.040″. In some embodiments the inner layer is a lowpermeability polymer. For example, the inner layer can be polyurethanewith a durometer between about 70 A and about 90 A, with a thicknessbetween about 0.0005″ and about 0.005″. In these embodiments theoccluding portion has a permeability rate of less than 0.5 ccair/hour/130 mmHg. The materials, thicknesses, and durometers can bevaried to achieve the desired permeability rate.

An exemplary advantage of using materials with these characteristics isthat the occluding portion is adapted to collapse upon deflation to asmall size to allow stool to pass. Additionally, these characteristicsaid in the insertion and removal of the device from the vagina.

FIG. 50 illustrates a portion of an exemplary device in which the devicecomprises an outer layer 319 with outer surface 320, and an inner layer321 with outer surface 322. Intermediate layer 324 is disposed betweenthe inner and outer layers. Intermediate layer can be a fluid (e.g.,saline) or other material that is adapted to create a low frictioninterface between the inner layer and outer layer. For example, theintermediate layer could be a low viscosity polymer. Outer surface 320can move with respect inner surface 322 since they are not coupled andbecause of the intermediate layer in between the two layers. FIG. 51illustrates the portion of device disposed within a vagina adjacentcervix 316 and vaginal wall 318. Outer surface 320 does not moverelative to the cervix, but rather it stays in place. Inner surface 322does move, however, relative to outer surface 320. This allows therelative motion (rubbing) to occur between the layers where the fluid orlow viscosity material is disposed. This prevents rubbing of the outerlayer against the cervix and vaginal wall, which can minimize or preventdiscomfort to the patient. Alternatively there can no material betweenouter layer 319 and inner layer 321; instead their surfaces have lowenough friction to permit motion, or their surfaces are coated with atleast one low friction coating.

The layered interface described above is also applicable to othervaginal devices that may rub against the vaginal wall from time to time.

An “extended configuration” as used herein is not limited to a presetextended configuration; “extended” is relative and refers to aconfiguration more expanded than a less expanded configuration.

FIGS. 52A-C illustrate an exemplary intra-vaginal device for the controlof stool passage. Device 350 includes occluding portion 352 andstabilizing portion 354. Occluding portion 352 is described above withrespect to any of the occluding portions and the mechanisms ofextension. Stabilizing portion 354 includes stabilizing body 351.Stabilizing body 352 includes curved portion 359 (see FIG. 52B thatfollows the general curvature of the extended occluding portion 352.Stabilizing body 351 includes portion 353 wherein two sections ofstabilizing body 351 are generally parallel to each other as they extendaway from occluding portion 352. The stabilizing body then extendsfurther laterally, forming lateral extension portions 355. Generallystraight portion 357 couples the lateral portions 355. Additionally, ascan be seen in FIG. 52B, stabilizing body curves upward in thetransition from portions 353 to portions 355. FIG. 52B illustratesrectum 358, uterus 366, pubic symphysis 364, inferior pubic ramus 362,and vagina 360. FIG. 52B shows device 350 positioned in the vagina suchthat the stabilizing portion 354 stabilizes occluding portion 352against the recto-vaginal septum above the perineal body, as isdescribed above. FIG. 52B additionally shows another effect the devicecan have on the anatomy by which it may help a variety of bowel-relatedissues. What is referred to herein as compressing the rectum can alsodescribe the modification of the ano-rectal angle. As shown in FIG. 52B,the extended device can push the rectum posteriorly which can have theeffect of enhancing the angulation between the rectum and the anal canal(illustrated by the termination of 358). This ano-rectal angle iscommonly associated with various bowel functions, such as continence anddefecation. FIG. 52C illustrates a posterior view of FIG. 52B (showingonly the device and a portion of the boney pelvis) illustrating lateralportions 355 of the stabilizing body extending further laterally thanthe boney inferior pubic 362. The upward curvature of stabilizingportion 354 can assist in stabilizing it against the boney structure ofthe pelvis.

The embodiment depicted in FIGS. 52 A-C, comprising a device body thatis narrow for a longer longitudinal span of the device may beparticularly advantageous in certain anatomies. For example, if a vaginais lacking in tissue slack or potential volume, maximum occlusion willbe gained in conjunction with minimal distension of the lateral walls.This embodiment highlights the general concept of minimizing lateraldisplacement with the device in the vicinity of the occluding portion,but providing sufficient lateral breadth elsewhere on the device suchthat it can maintain an appropriate position in the vagina.

The embodiment pictured in 52A-C also comprises a curved profile (whichis not necessarily in conjunction with the aforementioned narrow lateralspan). This curved profile can help maintain an advantageous positionwith respect to the pubic arch. The pubic arch narrows as it approachesthe pubic symphysis, so the closer to the pubic symphysis that a devicecan engage the pelvic anatomy to prevent expulsion, the more clearancethe lateral extents of the stabilizing body will have on either side ofthe vaginal opening and pubic arch. This curve can also follow thenatural curve of the pelvic floor or pelvic bones.

FIGS. 53A-F illustrate an exemplary torsion spring intra-vaginal devicefor the control of stool passage. FIG. 53A illustrates stabilizingmember 370, including torsion spring 372 and first and second arms 374and 376 extending from spring 372 (the rest of the device not shown forclarity). FIG. 53B illustrates the spring in an at-rest configuration.FIG. 53A illustrates arms 374 and 376 compressed by a user, such thatthe distance between the arms is decreased. The spring allows thestabilizing member to be compressed into a delivery configuration, andthen it will revert to the deployed configuration shown in FIG. 53B.FIG. 53C illustrates a side view illustrating the arms curving upsimilarly to the lateral portions in FIGS. 52A-C. FIG. 53D illustrates aperspective view of the device, wherein stabilizing member is disposedwithin generally tubular stabilizing body 380. Spring 372 is disposedwithin cushioning member 382, which is secured to occluding portion 378.FIG. 53E is a top view of the device, with arms 374 and 376 compressedcloser together. FIG. 53F is a top view showing the arms reverted totheir at-rest configuration.

In general, the spring allows the anterior portion of the stabilizingportion to be able to accommodates different widths, and apply moreconsistent force by being flexible. When the spring is in an at-restconfiguration and the arms are spread further apart, their lateral spanis greater and thus they have a lateral span greater than the width ofthe boney structures described above. The arms can therefore bestabilized behind and against the inferior pubic ramus. Additionally,the spring device applies a lateral force against the vaginal walls,just behind the pubic arch. This can help the stabilizing portion anchorbetter against the vaginal tissue since it is always pushing laterally.Additionally, flexion in this direction may accommodate motion or slightmisalignments better, as well as different anatomies.

FIG. 54 illustrates an exemplary torsion spring intra-vaginal device forthe control of stool passage. Device 390 includes a stabilizing portionthat includes spring 392 and arms 391 and 393 extending from the spring.The arms are spring loaded to apply a lateral force to the vaginal walland so that they will be stabilized behind the boney structure of thepubic arch. The spring action ensures that the device is at the widestpossible width that is appropriate for a given anatomy. The device alsoincludes occluding portion 394. The device in this figure also has armsthat have additional height, and preferably a convex surface providing agreater area of contact with the lateral wall.

FIG. 55 illustrates an exemplary torsion spring intra-vaginal device forthe control of stool passage. The device includes occluding portion 399.Stabilizing portion 395 includes spring 398 and spring-loaded arms 396and 397. Both arms have end portions 400 that have a step. The endportions 400 can assist in the stabilizing above and behind the boneystructure of the pubic arch.

FIG. 56 illustrates device 401 that includes occluding portion 402 andstabilizing portion 403. Stabilizing portion 403 includes body portion404 with lateral extensions 405. Springs 406 are disposed within lateralportions 405. Lateral portions 405 are adapted to be stabilized behindthe inferior pubic ramus, and springs 406 can accommodate a widervariety of movements and anatomies.

FIGS. 57A and 57B illustrate perspective and front views, respectively,of an exemplary stabilizing portion 410. Stabilizing portion 410includes body 411 and two flaps 412 that can be deformed toward body 411but are adapted to revert to the configuration shown in FIG. 57B. Theflaps apply forces generally laterally and down to engage the boneyinferior pubic ramus. The spring flaps also cause body 411 to be urgedupwards towards the pubic symphysis.

In some embodiments the stabilizing portion has an adjustable lateralspan to satisfy the anatomical needs of a specific patient. In someembodiments a sizing device can be used to measure one or moredimensions of a patient for the purpose of ordering or placing aspecific or custom device. In some embodiments the device is adjustableand is adapted to inform the user of the appropriate dimensions for thatparticular patient.

It may be beneficial to have stabilizing portions with lengths, widthsand/or curved configurations that are slightly different to accommodatethe needs of individual patients. In addition, it may be beneficial tohave occluding portions that have different lengths, widths, and/orcompliances. The devices herein can be adapted such that one or more ofthese dimensions and characteristics are adjustable. Depending on theconstruction of the device, the adjustment mechanisms may be different,but the devices would be adjustable.

Some of the stabilizing portions herein are adapted to be secured abovethe boney structure of the pubic arch, such as the inferior pubic ramus.The stabilizing portion needs to have the appropriate width, or lateralspan, so that it fits snugly behind the bone. If it is too narrow itwill fall out; and if it is too wide it won't fit and can causediscomfort. A device with an adjustable width, particularly at the front(anterior) end can help ensure stable positioning.

FIG. 58 illustrates a device with an adjustable width, or lateral span.Stabilizing portion 420 includes body 421 with an anterior portion 422and a posterior portion 423 that is adapted to be adjustable in thedirection of the arrows. Body 421 could be a shape memory material thatextends laterally upon the ambient (body) temperature being elevated.Once extended in the lateral direction they will be secured above theinferior pubic ramus. Body 421 could also be a deformable solid.

FIGS. 59A and 59B illustrate an exemplary stabilizing portion 430, whichincludes hub 433 to which arms 431 and 432 are secured and with respectto which the arms are adapted to rotate. The arms can be moved apartfrom one another such that the arms can be secured above and behind theinferior pubic ramus. The shape of the arms, or the stabilizing bodies,(in this embodiment and the other adjustable embodiments andspring-loaded stabilizing body embodiments described herein) can takemany shapes in addition to what is shown here, including curves in theaforementioned stabilization plane, similar to the top-view profile inFIG. 37B, but not necessarily forming a continuous loop, so thatsections can be moved relative to each other. These arms, or stabilizingbodies, can also have additional curvature out of this plane similar tothe device described in FIG. 52B. Additionally, the cross-sectionalprofile of the arms can vary along their length to create appropriateradii of curvature that is appropriate to adapt to the vaginal wall.Furthermore, these arms can be made from, or covered by a softbiocompatible material that reduces trauma to the vaginal walls.

FIG. 60 illustrates an exemplary stabilizing portion 435 that includes aratcheting mechanism that allows the arms to be ratcheted open to spreadapart arms 438 and stabilize them in place.

FIGS. 61A-B illustrates an exemplary stabilizing portion 440 includingbody 441 that is adapted to deform about locations 442 and 443 so thedevice assumes the deformed configuration shown in FIG. 61A. Forexpansion, the location 443 can deform such that the lateral bendingportions 442 extend further laterally to stabilize portion 440 in place.

FIGS. 62A and 62B illustrates an exemplary stabilizing portion 450including a threaded joint 451. By rotating an actuation member, thedistance between point A and B on body 451 is increased, and lateralportions 453 are widened.

FIGS. 63A and 63B illustrate an exemplary stabilizing portion 460 thatincludes first end 461 with ratcheting teeth, and a second end 462 withratcheting teeth. The teeth are adapted to ratchet to widen the lateralspan of the anterior portion.

FIGS. 64A and 64B illustrate an exemplary stabilizing portion thatincludes a hinge joint upon which arms 471 and 472 can be rotated. FIG.64B illustrates an exploded view. A braking mechanism can be used topress the hinged joint together such that angular movement between thearms is minimized, in other words fixing the configuration of the deviceafter it has been adjusted. In the exploded view, the 473 are shown in anon-braking orientation (i.e. not pressing the hinged joint together).

FIG. 65 illustrates an exemplary device 480 including occluding portion481. Stabilizing portion 482 includes arms 483 that are adapted to pivotaround pivot point 485. For delivery, the arms are moved closer towardsone another in the direction of arrows. For deployment the arms aremoved further apart to the configuration in FIG. 65. The arms havebulbous or rounded ends 484 to assist in anchoring the arms against theinferior pubic ramus. This embodiment is similar to the torsion springembodiment, but the pivot point is moved closer to the anterior portionof the device. This pivot point can be, for example, spring-loaded,adjustable, or even freely pivoting. This embodiment includes a pivotpoint on a device that utilizes a central rod to span the distancebetween the occluding portion and the adjustable stabilizing arms.

In some embodiments the occluding portion includes an extension memberthat extends below and above the general plane of the stabilizingportion, at least where the stabilizing portion is secured to theoccluding portion. FIGS. 66A and 66B illustrate an exemplary device 490that includes stabilizing portion 491 occluding portion 493. Stabilizingportion also includes portion 492 of extendable member 494. Extendablemember 494 is in this embodiment an inflatable material, and cancomprise one or more layers. Portions 492 and 493 are part of the samechamber and thus are in fluid communication. They could also be twodifferent chambers that are in fluid communication. It is also possiblefor the separate chambers to not be in fluid communication, wherein thechambers communicate with separate systems of valves and tubes. Finally,it is possible for the chambers to be reversibly in communication witheach other via a valve or system of valves. Portion 492 acts similar tothe cushioning members described above, but are part of the extendablemember. Stabilizing portion 491 is disposed completely around thesubstantial middle of the posterior end of extendable member 494. Insome embodiments the extendable member 494 is two section of elasticmaterial that are secured together by a generally inelastic materialaround its middle. The stabilizing portion can be secured to theinelastic bridging material without interfering with the extension ofthe elastic material on either side of the inelastic material.

FIG. 67 illustrates an exemplary device 500 that includes stabilizingportion 501 and occluding portion 502. The stabilizing portion alsoincludes extendable portion 503. Extendable member 504 forms a part ofthe occluding portion and a part of the stabilizing portion, even thoughthe two portions are in fluid communication. Portion 503 is adapted toprovide the benefits of the cushioning members described herein.

FIG. 68 illustrates an exemplary device 510 that includes stabilizingbody 511 and occluding portion 512. Device 510 is similar to device 500,but the device also includes annular cushioning member 513 secured toextendable member 514. Cushioning member 531 better accommodates acervix or other vaginal tissue and/or provides the device with aneffectively flatter end.

The expandable members described above as extending below, at, or abovethe plane of the stabilizing body are shown in this disclosure attachedto a stabilizing body of arbitrary shape. The characteristics of theexpandable members described above are equally applicable to otherstabilizing body structures contained or referenced herein.

In some embodiments the device is adapted such that the occludingportion extends away from the stabilizing portion but is in substantialalignment with the stabilizing portion. Exemplary device 530 shown inFIGS. 70A and 70B includes stabilizing portion 531 and occluding portion532 in an extended configuration. Occluding portion 532 is secured tostabilizing portion 531 and when extended is in substantial alignmentwith stabilizing portion 531. The relative positions of the stabilizingportion and occluding portions may have some advantages in certainanatomies. This design can also limit torque applied around axis 533 byforces “F” on the expandable member as shown. Axis 533 extends from theanterior end of the device to the proximal end of the device. Axis 534is shown and is generally orthogonal to axis 533. Force F shown actingon occluding portion 532 does not cause a rotation around thelongitudinal axis 533. This design exemplifies the effect of shiftingthe alignment between the occluding portion and the stabilizing portion.In this embodiment the two portions are in substantial alignment, andthus the relative angle between this is substantially 180 degrees. Theangle could be, in some embodiments, between about 90 degrees and 180degrees depending on the degree to which rotation or translation is anissue.

In some instances intravaginal devices may be subject to a loss ofstability and slip out of the vagina when a portion of the device isdislodged from the stabilization position behind the pubic arch, asdescribed above. Undesired rotation about the devices longitudinal axismay be a contributing factor to the instability of the device.

FIG. 71 illustrates an exemplary device 542 in which the device isadapted such that occluding portion 541 is disposed at an angle greaterthan 90 degrees relative to stabilizing portion 542. FIG. 71 alsoillustrates how even though stabilizing portion 542 is not completelyplanar, occluding portion is considered to be disposed at an anglerelative to a region of the stabilizing member directly adjacentoccluding portion 541. For example, the anterior end of stabilizingportion curved upward relative to a region of the stabilizing portiondisposed more posteriorly.

FIG. 72A illustrates stabilizing portion 551 stabilized in the pubicnotch 550. In some instances, in response to a torque applied to thedevice, the stabilizing portion can be dislodged from its stabilizedposition, as is shown in FIG. 72B.

The stabilizing portion can take on a variety of configurations, some ofwhich will not be described. FIGS. 73A-D illustrate an exemplary device560 with stabilizing portion 561 and occluding portion 562. FIGS. 73A-Dare perspective, side, front, and top views, respectively. Stabilizingportion 561 has an annular configuration and is not completely planar.However, the device shape is relatively flat in any given cross sectionalong the device's length, and therefore meets the descriptions forstabilizing body width/length/thickness relationships described above.Stabilizing portion 561 includes first portion 564 and second portion565 that is not in the plane generally defined by first portion 564.Line 563 is connected to occluding portion 562. This configuration maybe able to stabilize the stabilizing portion better against bones in thepubic notch.

Stabilizing portions in which there is some flexibility built in canenhance the stability and comfort for the patient. For example, if apatient bears down, a device that can flex can be less likely to bebecome dislodged, the “give” in the device may allow the device toconform more to the anatomy without causing discomfort. A stabilizingbody with more flexibility may have benefits over a stiffer device forstability. A flexible device lessens the transmission of a potentiallydislodging force from one portion of the device to another. An exemplarymaterial that can be incorporated into one or more portions of thedevice is ethylene vinyl acetate or other thermoplastics that has goodelasticity and biocompatibility. Additionally, a flexible device mayimpart less tension on the vaginal walls, or impart less tension thancan be overcome by the occluding portion force, so that rectal occlusionis not inhibited. The devices still preferable have enough strength andstiffness to keep the occluding portion in the right position againstthe recto-vaginal septum. For example, as the occluding portion extends,the occluding portion may try to push itself out of the vagina. Havingsome stiffness in the device therefore keeps the occluding back abovethe perineal body.

FIGS. 74A and B illustrate top views of an exemplary device 570including stabilizing portion. Device 570 includes generally annularshaped stabilizing portion 571 and an occluding portion. FIG. 74Aillustrates stabilizing portion 571 compressed along the longitudinalaxis, illustrating the flexibility of the stabilizing portion. FIG. 74Billustrates the stabilizing portion compressed in an axis that issubstantially orthogonal to the longitudinal axis of the device. Device570 also includes securing member 573, to which the occluding portion issecured as is the stabilizing body. Stabilizing portion 571 includes atubular stabilizing body, in which reinforcing member 572 is disposed.The tubular stabilizing body has a lumen extending therethrough adaptedto house spring reinforcing member 572 therein. Reinforcing member 572is in the form of a spring, similar to a portion of the reinforcingmember in the embodiment in FIGS. 38A-F. The device shown in FIGS. 74A-Bcould also have a dedicated cushioning member as does the embodiment inFIGS. 38A-F.

FIGS. 75A-E illustrate an exemplary device 580 with a flexiblestabilizing portion 581. The stabilizing portion includes a tubular bodywith spring 581 and 582 extending through the lateral portions of thetube to provide for anterior-to-posterior flexibility, which isillustrated in the difference between FIGS. 75D and 75E. Wireforms 583and 585 are disposed at the anterior and posterior portions,respectively, and are secured to the springs. Device 580 also includesoccluding portion 585. The anterior portion the stabilizing body extendsupward relative to the posterior portion of the stabilizing portion.

FIG. 76 illustrates exemplary stabilizing body 590 that has anteriorspring 591 and lateral springs 592 therein. The springs are coupled bywireforms 593. The posterior portion of stabilizing body 590 does nothave a reinforcing member therein, which provides for flexibility inthat region. The anterior portion of the stabilizing body extendsupwards.

FIGS. 77A and 77B illustrate stabilizing body 600 that has anteriorspring 601, posterior spring 602, and lateral springs 603 springs. Thesprings are coupled by wireforms 604 and 605. FIG. 77B illustrates thebody being flexed along the longitudinal axis of the device. Theanterior portion of the device extends upwards. A device withflexibility as shown in FIGS. 77A and 77B can also be flexed by bringingthe lateral sides together, without necessarily folding the device asshown in FIGS. 44A-C.

FIG. 78 illustrates exemplary device 610 wherein occluding portion 611extends in the superior direction relative to the stabilizing body.Stabilizing portion 612 includes anterior spring 613 and lateral springs614 (only one shown) disposed with a stabilizing body. The springs arecoupled by wireforms 615. By extending in the superior direction, thestabilizing body itself applies the force to the rectum, therebycontrolling the passage of stool. This embodiment additionally utilizeslateral springs to facilitate the deflection of the stabilizing bodyaround the occluding portion, as it deflects towards the rectum.

FIGS. 79A-B illustrate an exemplary stabilizing body 620, wherein aposterior spring 621 is disposed therein. Wireform 622 is disposedthrough the remainder of the stabilizing body, and is coupled to eitherend of spring 621. The stabilizing body has a configuration that isgenerally curved upwards in the anterior region.

FIG. 80 illustrates exemplary stabilizing body 630 with a generalS-curve configuration. Spring 631 and wireform 632 are disposed withinbody 630.

FIGS. 81A-B illustrate exemplary body 640 that has a general S-curveconfiguration. The reinforcing member includes lateral springs 641 andanterior spring 642. Wireforms couple the different spring sections.

FIGS. 82A-D illustrate an exemplary stabilizing body 650 that has aconfiguration in which the anterior portion is positioned upwardsrelative to the remainder of the body. The reinforcing member includesanterior spring 652, lateral springs 651, and posterior spring 653. Thesprings are coupled by the four wireforms 654 and 655. The springsprovide for flexibility in the anterior to posterior direction, as wellas foldability along the longitudinal axis, as is shown by thedifference between FIGS. 82C and 82D.

In some embodiments the occluding portion includes a force distributingfeature to distribute the forces applied to the extendable member over agreater area of the extendable member. In use, when the occludingportion is extended, the septum tissue applies a force to the occludingmember. In general, as an object pushes into a fixed-air-mass expandablestructure, the “reaction pressure” is proportional to the area of theobject/expandable structure interface. A narrow object will thus push infurther in the expandable structure than a wide object to reach the samereaction pressure. FIG. 83 illustrate the concept in which occludingportion 660 includes expandable member 661, wherein force F is beingapplied by a relatively narrow object. FIG. 84 illustrates an exemplaryoccluding portion 662 including expandable member 663 and cap 664secured to the expandable member 664. The cap material is stiffer thanthe expandable member material, and thus when force F is applied to thecap, the force applied to the expandable member is distributed over theinterface between the cap and the expandable structure. The interfacebetween the cap and the expandable member is greater than the interfacewould have been between the object and the expandable member. This canimprove the extendable member's ability to apply a force against vaginaltissue to occlude the rectum in the presence of objects pressing againstthe force. The cap creates a more defined force-applying surface.

FIG. 85A illustrates exemplary device 670 including occluding portion672 and stabilizing portion 671. Occluding portion 672 includesextendable member 673, upon which force F is applied in FIG. 85B. Theextendable member is deformed, as is shown. The force is essentiallylocalized at the location of application of the F. FIGS. 86A-Billustrate device 680 that includes stabilizing portion 681 andoccluding portion 682. Occluding portion 682 includes extendable member683 and cap 684. Cap 684 is a stiffer material than extendable member683, which can be, for example, a soft silicone material or any otherexemplary extendable member material as set forth herein. As shown inFIG. 86B, when a force is applied to cap 684, the force is distributedover the interface between extendable member 683 and cap 684. Thisresults in a more well-defined force applying surface on the occludingportion.

In some embodiments the cap is the same material as the extendablemember but has a thickness greater than thinner portions of theextendable material.

FIGS. 87A-B illustrate an exemplary occluding portion 690 that includesextendable member 692 and cap 691, which in this embodiment is athickened portion of the same or substantially similar material asextendable member 692 material. For example, both the extendable member692 and the cap can be made from a soft silicone, wherein the cap is athickened region of the soft silicone. Occluding portion also includesspring 693 disposed within the chamber formed by extendable member 692and cap 691. Extendable member 692 can have one or more layers as setforth herein. Cap 691 allows the spring to exert a force against theseptum in a uniform manner over a larger surface. Tube 694 providesfluid communication between the occluding portion and a region outsidethe occluding portion. Tube 694 allows air to escape the occludingportion as it is compressed, which also deforms the spring as shown inFIG. 87B. Once compressed, the tube is closed, preventing air fromreturning to the occluding portion, and the spring remains compressed.The occluding portion can then be reinflated to allow the spring, andthe occluding portion, to return to an extended state. The device can beinserted into the vaginal with the occluding portion in the non-extendedstate shown in FIG. 87B.

FIGS. 88A and 88B illustrate an exemplary device 700 that includesstabilizing portion 701 and occluding portion 702. Occluding portion 702has spring 703 therein that applies a force to the recto-vaginal septumvia the extendable member, or a cap as in the embodiment in FIGS. 87A-B.To compress the device from the extended state shown in FIG. 88A, avacuum is pulled on the occluding portion via line 704 to remove thefluid (e.g., air) from the occluding portion. This causes spring 703 tocompress to the configuration shown in FIG. 88B, and stool is allowed topass out of the rectum. Fluid can be reintroduced into the occludingportion to inflate the occluding portion to an extended state, whichallows the spring to revert to an extended state. In this embodiment thedevice is actively compressed to allow stool to pass.

A spring may be included in an occluding portion to help ensure that theextendable member collapses in a reproducible manner. Some extendiblemembers can fold and collapse into a number of different configurations.It may be advantageous for the extendable member to return to thenon-extended state in a substantially consistent manner each time. FIGS.89A-B illustrate this concept. FIG. 89A shows exemplary occludingportion 710 including extendable member 711 and spring 712 therein. Inthe non-extended configuration shown in FIG. 89B, extendable member 711collapses consistently to form plicated sections 713 of extendablemember 711. An extendable member that collapses in a substantiallyconsistent manner can make easier the determining of dimensions of theoccluding portion in non-extended states.

FIGS. 90A-C illustrate an exemplary device 720 that includes occludingportion 722 and stabilizing portion 721. Stabilizing portion 721includes a stabilizing body with a first portion 723 that has asubstantially half-ring configuration, and a second portion with agenerally linear configuration 724. The first portion 723 has an outerarc that subtends an angle of about 180 degrees. Occluding portion 722extends posteriorly from the posterior end of the stabilizing manner.FIG. 90A is a top view, FIG. 90B is a perspective view, and FIG. 90C isa side view. In this embodiment stabilizing portion 721 can be sized andconfigured such that the proximal end of stabilizing portion 721 does ordoes not extend into the posterior fornix. In embodiments in which itdoes not, the half-ring portion 723 and occluding portion 722 providesufficient structural support to stabilize the device and maintainoccluding portion against the septum in extended and non-extendedstates. Additionally, it may be possible with a device in thisembodiment to reconfigure the occluding portion to a configurationbetween an extended state and a non-extended state such that the rectumis not occluded, yet the occluding portion is maintained in position dueto, at least in part, forces applied to the septum from the partiallyextended occluding portion.

FIG. 91 illustrate an exemplary device 730 whose stabilizing portion 732is not a complete ring, but is more ring shaped than the embodiment inFIG. 90A-C. Portion 733 has an outer arc that subtends an angle greaterthan 180 degrees. The device includes occluding portion 731 and linearportion 734 of the stabilizing portion.

FIG. 92 illustrates an exemplary device 740 whose stabilizing portion724 is not a complete ring but has a general ring configuration and moreclosely approximates a complete ring than the configuration of thestabilizing body in the embodiment in FIG. 91. First portion 743 of thestabilizing portion has an outer curve that subtends an angle betweenabout 270 degrees. The device includes occluding portion 741 and linearportion 744 of the stabilizing portion.

In these embodiments the first portion can have an arc that subtends anangle between 180 and 360 degrees. In some embodiments the angle can bebetween about 90 and about 180 degrees.

FIGS. 93A-B illustrate conceptually how device 750, which has a moresuperior and posterior occluding portion 752 relative to stabilizingportion 751 may be less effected by lateral tension than a similardevice 760 that includes occluding portion 762 that is more inferiorrelative to stabilizing portion 761.

In some embodiments the occluding portion is adapted to be inflatedand/or deflated using a fluid inflation device that is adapted to bedisposed outside of the patient's vagina. FIG. 94 illustrates system 850including stool control device 851 and inflation device 852. Device 851can be any of the stool control devices herein. Device 851 includesinflation line 857 in fluid communication with occluding portion 858.The pump has a fluid inflow end 860 and an outflow end 855. Inflationdevice 852 also includes relief valve 853. Inflation device 852 includespump 854 that, upon compression, pulls fluid from inflow end 860 andpumps it out of outflow end 855, in the direction of the arrows shown.

In an exemplary method of use, when the occluding portion isnon-extended, the outflow end 855 is reversibly coupled to inflow end859 of line 857, as shown in FIG. 95. The can be secured by a frictionfit where outflow end 855 is sized to fit within inflow end 859. Theconnection could also include a luer lock or any other way to reversiblysecure the two components. The pump is squeezed by the user and air ispumped from the inflow end 860 towards the occluding portion. Reliefvalve 853 is adapted to prevent over-pressurization. Including reliefvalve 853 allows the maximum allowed pressure for the occluding portionto be established at the relief pressure valve. If the pressure in theoccluding portion exceeds the relief valve pressure, inflow air isdiverted through the relief valve rather than being pumped into theoccluding portion. The system can be modified such that there is anindication provided to user (e.g., an audible, visual, or tactile) whenthe air is being released from the relief valve. The user then knows tocease the pumping. Alternatively, the user can simply pump many times,knowing that the relief valve will prevent the occluding portion fromoverextension. Inflation device 852 can be easily held by the user toinflate the occluding portion. Once the occluding portion is adequatelyextended, inflation device 852 is decoupled from device 851.

Inflation device 852 is also used to pump fluid out of the occludingportion. FIG. 96 illustrates that to remove the fluid from occludingportion to move it to a non-extended state, inflation device 852 isagain reversibly coupled to end of line 859, but inflow end 860 issecured to device end 859. The direction of flow in this orientation isshown in the direction of the arrow in the figure. The pump isrepeatedly compressed by the user, which pumps air from the occludingportion and out outflow end 855. The user can compress the pump manytimes, known that after a few pumps essentially all of the fluid will beremoved from the occluding portion and in a non-extended state. Anindication (audible, visual or tactile) can also be provided to indicatewhen the occluding portion is in a sufficiently non-extended state.

At least one of the two ends of inflation device 852 can have anindicator associated with it to indicate to the user which end should becoupled to line 857 to inflate the occluding portion and which endshould be coupled to line 857 to deflate the occluding portion. Forexample, in one embodiment one end has a color to indicate that it isthe inflating end.

In FIG. 97, exemplary inflation device 870 is reversibly secured todevice 851, and includes pressure gauge 872 that is adapted to displaythe pressure within the occluding portion.

In some embodiments the inflation device includes an indicator to theuser that the occluding portion has been inflated sufficiently toocclude the rectum, and/or that the occluding portion has been deflatedsufficiently to allow stool to pass. In some embodiments there can be avisual indication, such as a green light to indicate passage (i.e.,sufficient deflation) and a red light to indicate occlusion (sufficientinflation).

In some embodiments the pump is electronically controlled and does notrequire human compression. For example, in some embodiments theinflation device includes an electronically controlled pump that, uponturning on the device, pumps air through the line in one of twodirections. The inflation device is coupled to the stool control device,and a user interface on the inflation device allows the user to depressa first button for inflation (flow into the device) or a second buttonfor deflation (flow out of the device). There can also be a singletrigger and a switch to indicate whether the trigger instigatesinflation or deflation. The inflation device could be programmed todetermine if the pressure in the occluding exceeded a maximum allowedpressure, which would result in the pump stopping. The inflation devicecould also be programmed to determine when the pressure was low enoughthat the occluding portion was sufficiently deflated, which would alsoresult in the pump stopping. Alternatively, the power supplied to thepump can be regulated such that it can only move fluid across a pressuredifferential of a given magnitude, beyond which the inflation devicefails to move more fluid.

In another embodiment, there is only one interface trigger and theinflation device has two connections, similar to the manual pumpdescribed above. For this embodiment, the inflation device can beconnected to the stool control device via one fitting to inflate thedevice, and a second fitting to deflate the device.

One aspect of the disclosure is a system for the control of passage ofstool, the system including an intra-vaginal device sized and configuredto be inserted into an adult human user's vagina, wherein said devicecomprises an adjustably occlusive element adapted to reversibly apply aforce that at least partially occludes the user's rectum, and anocclusion control mechanism that is adapted to control the amount ofocclusion.

In some embodiments the occlusion control mechanism is adapted to adjustthe amount of occlusion to an amount set by the user. The amount ofocclusion can be controlled by a volume of fluid introduced into saidocclusive element. The amount of occlusion can be controlled by apressure of fluid introduced into said occlusive element. The amount ofocclusion can be controlled by either a volume of fluid or a pressure offluid present in the intra-vaginal device. The occlusion controlmechanism can include a mechanism for limiting the pressure or volume ofthe fluid. The limiting mechanism can be adapted to vent fluid when theset amount of pressure or volume is present in the occlusive element.The occlusion control mechanism is adapted to remove fluid from theintravaginal device, thereby controlling the amount of occlusion.

In some embodiments the occlusion control mechanism controls the amountof occlusion by controlling the amount of force applied to therectovaginal septum.

In some embodiments the occlusion control mechanism is adapted toprovide the user with at least one indication of the amount ofocclusion. The amount of occlusion can be controlled by a pressure offluid within the occlusive element, and the indication can indicate theamount of pressure in the occlusive element.

One aspect of the disclosure is a method of use for an intravaginalrectal occlusion device, the method comprising inserting theintravaginal device into a user's vagina; coupling to the intravaginaldevice a device for controlling the amount of occlusion; actuating thecontrolling device to increase occlusion when passage of stool is notdesired; and actuating the controlling device to decrease occlusion whenpassage of stool is desired. In some embodiments the increasingocclusion step includes the step of increasing the amount of fluid inthe occlusion device until there is an excess of fluid and then allowingthe excess of fluid to escape through at least one relief valve.

One aspect of the disclosure is a method for controlling the amount ofrectal occlusion provided by an intravaginal device, the methodcomprising inserting the intravaginal device into a user's vagina;introducing fluid into the intravaginal device to extend the occlusiveportion of the device; measuring the amount of extension of theocclusive portion; measuring the amount of occlusion of the user'srectum to determining an appropriate amount of occlusion; andconfiguring an occlusion control mechanism to repeatably extend theocclusive portion of the device to the amount of occlusion determined tobe appropriate.

In some embodiments the step of measuring the amount of extension of theocclusive portion includes the step of measuring the pressure of thefluid in the intravaginal device. The measuring step can include using apressure gauge or pressure transducer.

In some embodiments the step of measuring the amount of extension of theocclusive portion includes the step of measuring the volume of the fluidintroduced into, or removed from, the intravaginal device.

In some embodiments measuring the amount of occlusion of the user'srectum includes the step of performing a rectal exam.

In some embodiments measuring the amount of occlusion of the user'srectum includes the step of visualizing the rectum via ultrasound.

In some embodiments the configuring step includes the step of adjustinga relief valve coupled to the occlusion control mechanism.

In some embodiments the configuring step includes the step of coupling apre-set relief valve to the occlusion control mechanism.

In some embodiments the configuring step includes the step of adjustinga relief valve coupled to the intravaginal device.

In some embodiments the configuring step includes the step of coupling apre-set relief valve to the intravaginal device.

In some embodiments measuring the amount of occlusion includes usinganorectal manometry or defecography.

In some embodiments, the fluid in the occluding portion can be releasedthrough a fitting that allows for the natural release of the fluidrather than the fluid being pumped out. Some embodiments may comprise anelastic or spring member that facilitates collapse of the occludingportion, helping to force fluid out of the occluding portion.

FIG. 98 illustrate an exemplary stool control device 880 which includesoccluding portion 881, stabilizing portion 884, fluid line 882, andfinger pump 883. Finger pump 883 is sized such that it can be squeezedbetween two average adult fingers. Pump 883 is adapted to pump fluid inthe direction of F. It may be beneficial to have the small pump 833irreversibly fixed at the end of tube 882. This can alleviates the needto carry a larger pump. It can also allow for on-the-fly adjustment ofthe pressure or discrete periodic re-inflation. Pump 883 can also beadapted to be reversibly attached. Pump 883 can be reversed in directionto remove fluid from the occluding portion as well. Or a pump such asthe pump in FIGS. 94-97 can be used when fluid is to be removed. Pump883 can also be removed to allow for a pump such as in FIGS. 94-97 toinflate the occluding portion.

FIGS. 99 and 100A-B illustrate an additional way to release fluid (e.g.,air) from within the occluding portion. It is more generally a way torelease air from a tube. It could be particularly useful if the pump orvalve does not have a way to release the air from the occluding portion.The device includes coupling 900 between line 890 and fitting 891 thatis secured within the proximal end of line 890. The proximal end offitting 893 is closed to ambient air. Coupling 900 can be used in thefinger pump in FIG. 98, or it can simply be a fitting that is coupled tothe inflation line that in fluid communication with the occludingportion. Fitting 891 can be considered a valve, a cap, nozzle, etc.

FIGS. 100A and 100B illustrate coupling 900 showing apertures 895 in theline 890 that all the way through line 890. Line 890 is an elastomericmaterial, or other type of material with similar properties. When it isfit over nozzle fitting 891, seal 894 (see FIG. 100A) is created betweenthe inner diameter 892 of line 890 and the outer surface 893 of fitting891. Due to the seal, air cannot escape from inside line 890 apertures895. When tension is applied to fitting 891, as shown in FIG. 100B, line890 is stretched, including apertures 895, as shown in FIG. 100B. Whenthe distal end of fitting 891 clears at least a portion of theapertures, as shown in FIG. 100B, fluid is released from within line 890out through the apertures 895 in the direction of arrows F.

A device similar to finger pump can act as the fitting, but rather thanbe squeezed to release air, it is tensioned as set forth above. This canallow for convenient and easy fluid release from the occluding portion.

An alternate embodiment may include a separate or integral valve that ismanually operated to allow the release of fluid.

In some embodiments the device, or system components secured thereto(such as an externally disposed inflation control device), are adaptedto control the amount of occlusion in the occluding portion. Forexample, in some embodiments the inflation device includes safetyfeatures (e.g., the relief valve described above) adapted to preventover extension of the occluding portion. In some embodiments the systemincludes an adjustable interface mechanism that is pre-set to differentextension amounts. For example, in some embodiments the interface has anadjustable setting that allows the user to select if they want toinflate or deflate the occluding portion. Once selected, the interfaceautomatically inflates or deflates to pre-set limits. Alternatively, insome embodiments the interface has different levels of occlusion thatcan be selected. For example, the interface could be pre-set withcompletely occluded, half-occluded, and minimally occluded settings. Theuser can select which they desire, and the system will automaticallyfill the occluding portion to a pre-set limit. Alternatively, once theuser selects the desired level of occlusion, the user then manuallyinflates the occluding portion but the interface prevents the user frominflating the occluding portion more than the pre-set limit.

In some embodiments an interface mechanism includes an indicator that isadapted to alert the user (e.g., audio, visual, tactile) when the deviceis at a certain level of expansion. For example, the interface can beadapted to indicate to the user when the occluding portion is fullyextended, or completely non-extended. The interface mechanism may alsoalert the user if the occlusion has fallen over time to a level below acertain threshold.

In some embodiments the system includes a display adapted to display atleast one value related to the degree of occlusion (e.g., a pressuregauge, a volume meter, a displacement gauge, etc.).

The system can also be tailored to the comfort level of a particularpatient. A volume of the occluding portion, pressure, length ofextension, or other parameter, that produces an optimum combination ofocclusion and patient comfort can be tailored determined and programmedinto the system. In some instances an initial “fitting” takes placewhich includes a digital rectal exam. For example, as the occludingportion is extended, the pressure, volume or length is displayed orotherwise made available for the user or physician. The control deviceis then programmed or otherwise adapted to repeatedly extend the deviceto one or more of these settings. Ultrasound or other imaging techniquescan also be used to determine occlusion, as can balloons and manometers.

In some uses a fitting tool is used to size the patient's vaginaldimensions to help select the right size for the device, or forindividual portions or components of the device. The fitting tool can beexpandable device that is inserted into the vaginal vault in anunexpanded configuration, and is then expanded inside the vagina.

FIGS. 101-103 illustrate an exemplary modular design for anintra-vaginal stool control device. Modular designs can be used tointerchange components of the device. For example, a variety ofoccluding portion can be coupled to a variety of stabilizing portions tofind the best fit for a patient. For example, a balloon that fits mostoptimally for a given patient can be combined with a stabilizing bodythat fits optimally for that patient. In addition, a modular designallows for the replacement of a component that needs to be replaced,such as when an occluding portion wears out and needs to be replaced.Because the devices are so easily removed from the vagina, modulardesigns make is easy to replace only a portion of the device.

There may be kit of occluding portions with different dimensions (e.g.,width, height) and a kit of stabilizing portions with differentdimensions or shapes (e.g., width, length), and an optical selection oftwo components can be made.

FIG. 101 illustrates device 900 including stabilizing portion 901 thatis controllably detached from occluding portion 902. Occluding portion902 includes extendable member 903, button 904, and sleeve 905, whichthat is adapted to open to allow the release of stabilizing portion 901.

One aspect of the disclosure includes rectal occlusion devices that arepassive in that they do not require external actuation to allow stool topass. The devices include an occluding member that has a pre-set amountof strength (e.g., pressure, spring force, etc.). The strength amountprevents small amounts of stool from passing. However, when sufficientstool pressure is generated against the passive occluding member, theoccluding member is deformed out of an occluding position and the stoolforces its way past the occlusion and is expelled.

Alternatively, a device, static or not, can be utilized by the user inconjunction with her control over various muscles in her pelvis andabdomen. In this use embodiment, the device can prevent the passage ofstool until the user changes her musculature (relaxes or tightens) in away that then allows the device to be deflected by the stool. Similarly,a device, static or passively extendable, meeting the generalrequirements related to dimensions, geometrical configurations andprotective elements established herein may apply sufficient force toprevent the passage of unwanted stool, but when sufficient stool ispresent, or sufficient defecatory reflexes are triggered in the user'sbowel, stool is allowed to pass by either passing around the occlusiveportion or displacing the occlusive portion (and possibly the entiredevice) temporarily to a different position as the stool passes. In thisembodiment, extension control mechanisms such as inflation tubing neednot be necessary.

FIG. 104A illustrates passive occluding device 910 that includesstabilizing portion 911 and passive occluding member 912. Passiveoccluding member 912 is in a fully extended state in FIG. 104A and isoccluding rectum 103. Alternatively, the occluding portion could alsoinclude an extendable member surrounding spring 912 like in theembodiment in FIGS. 87A-B. In FIG. 104B, when stool 916 has enough mass,it compresses the spring away from the rectum, allowing the stool topass. Once the stool passes, the spring extends back towards an at-restconfiguration and again occludes the rectum.

In alternative embodiment the passive occluding portion could be adaptedto deflect in the inferior direction rather than being compressed. Forexample, the spring could be forced towards the stabilizing portionrather than being compressed.

In some embodiments the device or system includes a stool sensingdevice. In general, the stool sensing device notifies the patient ifthere is stool that needs to be evacuated. Some patients may havedecreased sensation in their rectum as a result of the conditions thatalso lead to FI. Alternately, the device may prohibit stool frombuilding up in an area of the rectum that is sensitive to filling. Ineither case, the user may not be able to determine, at least for sure,if there is accumulated stood that needs to be evacuated. In thesesituations it could be helpful to notify the user when stool is presentand needs to be evacuated.

FIGS. 105A-B illustrate exemplary device 920 that includes pressuregauge 925. Device 920 also includes stabilizing portion 921 andoccluding portion 922. Pressure gauge 925 is coupled to fluid line 924.When the stool mass is small (FIG. 105A), there is little pressure onthe occluding portion and the pressure gauge gives a low reading. Whenthe stool mass increases (FIG. 105B), the mass applies greater pressureto occluding portion 922, which results in a higher gauge reading. Thepressure sensing mechanism is connected to an alarm, a visual display,or a tactile indicator. FIGS. 106A-B illustrate an exemplary tactileindicator 930, which is in fluid communication with occluding portion922 via line 931. Indicator balloon 930 increases in size as pressureincreases in the occluding portion and more fluid is driven to theindicating balloon.

When the device includes a stool sensing device, the sensing device canbe sensitive to pressure from the body if the user assumes certainpositions, such as bearing down, even though there may not be any stoolin the rectum. To eliminate high pressure reading from body movement, aspring or other damping mechanism can be incorporated into the device toreduce pressure changes based on body movements. Alternatively, anelectrical interface can be used and programmed to distinguish betweenpressure increases due to stool versus pressure increases from changingbody positions.

One aspect of the disclosure is a stool control device that utilizes twomagnets to bring regions of tissue together to occlude the rectum. Amagnetic force is created between a pole positioned in the vagina and apole in the rectum to create the occlusive force.

FIG. 107A illustrates an intravaginal device 940 that includes a body941 and a magnet 942 secured thereto. A second magnet 943 is positionedposterior to the rectal lumen. The magnet is shown implanted in thislocation, but the magnet can be disposed there using a sling (see FIG.110). Device 940 is inserted into vaginal vault 944, and the magneticattraction between the magnets urges the walls of the rectum together,occluding the rectum, as is shown in FIG. 107B.

FIG. 108 illustrates intra-vaginal magnetic device 950 with handlingstring 951 attached thereto for easy handling and removal from thevagina. FIG. 109 illustrates diaphragm-like device 961 with magnet 962secured thereto.

To allow stool to pass, the magnetic attraction can be disruptedmechanically, or by electromagnetic control. Or, in some instances, itcan be displaced by a sufficient amount of stool or pressure. The sizeof the magnets can be modified to control the amount of desired magneticforce. Cushioning elements can surround the magnets to prevent erosionwhen opposite walls are held together.

FIG. 110 illustrates an alternative way to secure the second magnet inplace. Sling 971 with magnetic portion 970 secured thereon is wrappedaround the rectum with the magnetic portion 970 in place as shown inFIG. 110. The pubic symphsis 974, anal canal 973, and coccyx 972 areshown.

Potential benefits of increasing the contact surface between theoccluding and adjacent material in response to a force on the occludingportion can similarly apply to the stabilizing portion and how it isstabilized against boney tissue. FIG. 111A is a side view of exemplarydevice stabilizing portion 980 that includes anterior portion 982 andposterior portion 981. Anterior portion 982 and lateral portions arestabilized proximal to the pubic notch as set forth above. Anteriorportion 982 has maximum thickness T1 that is greater than a maximumthickness T2 of posterior portion 981. The increased thickness in theanterior portion increases the interface area between anterior portion982 and the vagina in the area of the pubic notch. The forces applied byanterior portion 982 on the vagina in that area are distributed over alarger surface area than they would be if anterior portion 982 had thesame thickness as posterior portion 981.

FIG. 111B illustrates exemplary stabilizing portion 990 that includesanterior portion 992 and posterior portion 991 that substantially equalthicknesses T1 and T2, respectively.

FIG. 112 illustrates an exemplary stabilizing portion 1000 that includesa distal end 1001 that extends upwards relative to proximal end 102 tohelp stabilize it relative to boney structure 1003.

One or more components of the device can be made from a shape memorymaterial that is adapted to revert to a shape memory configuration uponbeing heated above the materials transition temperature (the materialcan also have superelastic properties as well). For example, thestabilizing member can be adapted to revert to a stabilizingconfiguration from a delivery configuration when elevated towards bodytemperature. In some embodiments one or more components becomes more orless rigid when exposed to body temperature compared to room temperatureor other temperature less than body temperature. For example, thestabilizing portion could have one or more shape memory material thereinthat are adapted to become more or less rigid when exposed to the bodytemperature.

FIGS. 113A-C illustrate how the stabilizing portion can have two (ormore) modular components that be disengaged from one another and securedto other components. In this embodiment there are three possibleposterior portions 1010, 1020, and 1030, any one of which can becombined with any one of the three possible anterior portions 1040,1050, and 1060. This allows for the mixing and matching of anterior andposterior portions of the stabilizing body, which allows for a greatervariety of possible width, length, and thickness combinations. This canassist in obtaining a device fit optimized for a particular patient.There can be a kit of any possible number of anterior portions andposterior portions that can be selected from. The length of members1010, 1020, and 1030 increases, respectively, from member 1010 to member1030. The widths are shown to vary slightly. The width of members 1040,1050, and 1060 increases, respectively, from member 1040 to member 1060.Any of these members can be adapted to mate with a modular occludingportion, examples of which are set forth herein.

FIG. 114 illustrates an exemplary intravaginal device 1070 forcontrolling stool. The posterior end 1078 of occluding portion 1072 isslightly offset from the posterior end of stabilizing portion 1071.Specifically, the posterior end of stabilizing body 1074 extends furtherposteriorly than the posterior end of extendable member 1078.Stabilizing portion 1071 is sized and configured to stabilize occludingportion 1072 in the area of the pubic notch as set forth above.Stabilizing body 1074 extends upwards towards the anterior end of thebody. Stabilizing portion 1071 includes optional cushioning member 1076,examples of which are provided herein. When the extendable member 1078is extended, cushioning member 1076 (or simply the properties of thestabilizing portion in that area) prevent trauma to the anterior portionof the vagina in the posterior end of the vaginal vault. Cushioningmember 1076 is disposed substantially opposite to the direction ofextension of occluding portion, designated generally as direction “E” inFIG. 114.

FIG. 115 illustrate a top view of an anterior portion of exemplarystabilizing portion 1090. Stabilizing portion 1090 includes body 1091with springs 1092 disposed therein. The stabilizing portion alsoincludes bumpers 1093 on an outer portion of the body 1091. Bumperscould be separate components secured to body 1091. In some embodimentsthey are a polymeric material melted to body 1091 using a heat shrinktubing technique. Bumpers could be the same material as body 1091, butare a thickened portion of body 1091. In these cases bumpers can beconsidered part of body 1091. Bumpers 1093 can also be incorporated inembodiments in which the stabilizing portion does not have a stabilizingmember therein. In this embodiment bumpers have a length that is aboutthe same as the length of springs 1092, although the bumpers can beshorter or longer.

The bumpers can reduce the forces applied from the springs onto vaginaltissue, and can thus minimize trauma to vaginal tissue. Also, if bumpersare used on corners, as is this embodiment, the bumpers prevent thesprings from forming acute edge, which can also help prevent discomfortor tissue damage. Bumpers 1093 can provide similar functionality tocushioning member described herein. It is thus contemplated that thedevices herein can have cushioning elements where they are expectedapply the most force to bodily structures, thus preventing discomfortand possible tissue damage.

Any of the components from any of the embodiments herein can beincorporated into any of the other embodiments or replaced with similarcomponents from other embodiments unless it is specifically stated tothe contrary.

What is claimed is:
 1. An intravaginal device for the control of passageof stool in an adult human female user, the device comprising: anintravaginal stabilizing portion having a central lateral axis and aproximal portion and a distal portion, each on opposite sides of thecentral lateral axis, the proximal portion being configured to bepositioned in a superior portion of a vaginal cavity of the user; and anexpandable member having a dome-shaped portion, the dome-shaped portionbeing positioned substantially entirely within the proximal half of thestabilizing portion, the expandable member having an expanded state anda retracted state, wherein the stabilizing portion is sized andconfigured to fit entirely within the user's vagina with a longitudinalextent of the stabilizing portion extending substantially along a lengthof the vagina to hold the expandable member in contact with arectovaginal septum and proximal to a perineal body of the user tocontrol the passage of stool through a rectum of the user.
 2. Theintravaginal device of claim 1 wherein the device is sized andconfigured to maintain position and stability in the user's vaginathrough engagement of internal vaginal anatomy during repeatedextensions of the dome-shaped portion.
 3. The intravaginal device ofclaim 1 wherein the dome-shaped portion has a lateral span less than alateral span of the stabilizing body.
 4. The intravaginal device ofclaim 1 wherein the dome-shaped portion has a lateral width of 20-60 mm.5. The intravaginal device of claim 1 wherein a lateral span of thestabilizing portion proximate to the dome-shaped portion is less than alateral span of the stabilizing portion not proximate to the dome-shapedportion.
 6. The intravaginal device of claim 1 wherein the dome-shapedportion is disposed in a posterior region of the stabilizing portion. 7.The intravaginal device of claim 1 wherein the thickness in theextension direction of the stabilizing portion is less than the lengthin the extension direction of the dome-shaped portion when thedome-shaped portion is fully extended.
 8. The intravaginal device ofclaim 7 wherein the thickness in the extension direction of thestabilizing portion proximate to the dome-shaped portion is less thanthe length in the extension direction of the dome-shaped portion whenthe dome-shaped portion is fully extended.
 9. The intravaginal device ofclaim 1 wherein the thickness of the stabilizing portion in theextension direction is less than the width of the stabilizing portion ina direction perpendicular to the extension direction.
 10. Theintravaginal device of claim 1 wherein an anterior side of thestabilizing portion is planar.
 11. The intravaginal device of claim 1wherein the stabilizing portion comprises a structural perimetersurrounding a substantially open space.
 12. The intravaginal device ofclaim 10 further comprising a support structure in an open space adaptedand configured to support the dome-shaped portion.
 13. The intravaginaldevice of claim 1 further comprising a cushioning member adapted toreduce trauma to the user's vaginal tissue.
 14. The intravaginal deviceof claim 13 wherein the cushioning member is disposed proximally on thedevice so as to be in the proximity of the cervix or vaginal cuff whenthe device is inserted into the user's vagina.
 15. The intravaginaldevice of claim 13 wherein the cushioning member is disposed opposite tothe dome-shaped portion.
 16. The intravaginal device of claim 13 whereinthe cushioning member comprises a part of the device that is moreflexible than a part of the stabilizing portion.
 17. The intravaginaldevice of claim 13 wherein the cushioning member comprises an outerlayer of a material disposed over an inner gel or gel-like material. 18.The intravaginal device of claim 13 wherein the cushioning membercomprises a part of the device that has a greater contact surface areathan a part of the stabilizing portion.
 19. The intravaginal device ofclaim 1 wherein the dome-shaped portion is inflatable and has an innermaterial that is less permeable to air than an outer material of thedome-shaped portion.
 20. The intravaginal device of claim 1 furthercomprising a fluid inflation device adapted to inflate the dome-shapedportion, the fluid inflation device comprising a valve adapted to limitthe force applied to the rectovaginal septum.
 21. The intravaginaldevice of claim 1 wherein the dome-shaped portion is positioned entirelywithin the proximal half of the stabilizing portion.